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U.S. Food & Drug Administration 1 2 (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public). Import Alert # 9932 Published Date: 12/13/2016 Type: DWPE Import Alert Name: "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION" Reason for Alert: NOTE: Revision to this Import Alert dated July 21, 2014 revises the Reason for Alert and Charge sections to change the word "agency" to "agent". Changes are bracketed by three asterisks (***). As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections of foreign manufacturers who produce FDAregulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreign manufacturer and schedule the establishment inspection; however, there is no such requirement to do so. Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined with other evidence, provides an appearance that the firm's products are manufactured, processed, or packed under insanitary conditions. The Red List identifies firm(s) that have offered FDAregulated articles for import into the United States and yet refused to allow the completion of an FDA inspection of their foreign establishment(s) for the purpose of determining establishment conditions and compliance with applicable laws and regulations, for example compliance with FDA's LowAcid Canned Food regulation, 21 C.F.R. Part 113. On the basis of a refusal from the firm(s), listed on the Red List, combined with other evidence, it appears that their articles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the act; therefore such articles are subject to refusal of admission into the US. The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. Section 306 of FSMA, codified in section 807 of the FD&C Act (21 U.S.C. 384c(b)), provides FDA with the authority to refuse admission of food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment. For the purposes of this charge, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24hour period after such request is submitted, or after such time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment. Foreign factories, warehouses, or other establishments who refuse to permit entry of United States inspectors or other individuals, duly designated by the Secretary, to inspect their factories, warehouses, or other establishments will be listed on the Red List of this Import Alert, food products from those facilities are subject to refusal of admission as set forth in section 807 of the FD&C Act. The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Section 707 of FDASIA added a new section 501(j) to the FD&C Act, making a drug adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or ***agent*** of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug that have been manufactured, processed, packed, or held in any factory, warehouse, or establishment of which the owner, operator, or ***agent*** has delayed, denied, or limited an inspection, or refused to permit entry or inspection, appear to be adulterated and are subject to refusal under section 801(a)(3) of the FD&C Act. Guidance: Districts may detain without physical examination all products from the firm(s) identified on the Red List to this import alert. NOTE: If an article is subject to Refusal of Admission per Section 801(a)(1) or 807(b) of the FD&C Act, FDA considers submission of analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the FD&C Act precludes reconditioning under Section 801(b) of the FD&C Act. Products imported from the firm(s) listed on the Red List to this import alert should remain subject to detention without physical examination until an FDA inspection is completed. Firms may provide copies of inspection reports for inspections performed by third parties only to assist FDA in prioritizing inspection requests. Import Alert 9932 FDA Home 3 Import Program 4 Import Alerts Imports Alerts by Number Import Alert

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Page 1: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

U.S. Food & Drug Administration

1

2

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding themanufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and doesnot operate to bind FDA or the public).

Import Alert # 9932Published Date: 12/13/2016Type: DWPEImport Alert Name:"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENTINSPECTION"

Reason for Alert:NOTE: Revision to this Import Alert dated July 21, 2014 revises the Reason for Alert and Charge sections to change the word"agency" to "agent". Changes are bracketed by three asterisks (***).

As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishmentinspections of foreign manufacturers who produce FDAregulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may contact the foreign manufacturer and schedule the establishmentinspection; however, there is no such requirement to do so. Access to these facilities is a critical aspect of protecting the health andsafety of US citizens from unsafe products of foreign origin.The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined withother evidence, provides an appearance that the firm's products are manufactured, processed, or packed under insanitaryconditions.

The Red List identifies firm(s) that have offered FDAregulated articles for import into the United States and yet refused to allowthe completion of an FDA inspection of their foreign establishment(s) for the purpose of determining establishment conditions andcompliance with applicable laws and regulations, for example compliance with FDA's LowAcid Canned Food regulation, 21 C.F.R.Part 113. On the basis of a refusal from the firm(s), listed on the Red List, combined with other evidence, it appears that theirarticles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the act;therefore such articles are subject to refusal of admission into the US.

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. Section 306 of FSMA, codified in section 807 ofthe FD&C Act (21 U.S.C. 384c(b)), provides FDA with the authority to refuse admission of food into the United States if it is from aforeign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of theforeign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, uponrequest, to inspect such factory, warehouse, or other establishment. For the purposes of this charge, such an owner, operator, oragent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit aninspection of a factory, warehouse, or other establishment during the 24hour period after such request is submitted, or after suchtime period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.

Foreign factories, warehouses, or other establishments who refuse to permit entry of United States inspectors or other individuals,duly designated by the Secretary, to inspect their factories, warehouses, or other establishments will be listed on the Red List ofthis Import Alert, food products from those facilities are subject to refusal of admission as set forth in section 807 of the FD&C Act.

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Section 707 of FDASIAadded a new section 501(j) to the FD&C Act, making a drug adulterated if it has been manufactured, processed, packed, or held inany factory, warehouse, or establishment and the owner, operator, or ***agent*** of such factory, warehouse, or establishmentdelays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug that have been manufactured,processed, packed, or held in any factory, warehouse, or establishment of which the owner, operator, or ***agent*** has delayed,denied, or limited an inspection, or refused to permit entry or inspection, appear to be adulterated and are subject to refusal undersection 801(a)(3) of the FD&C Act.

Guidance:Districts may detain without physical examination all products from the firm(s) identified on the Red List to this import alert.

NOTE: If an article is subject to Refusal of Admission per Section 801(a)(1) or 807(b) of the FD&C Act, FDA considers submission ofanalytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held underinsanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the FD&C Act precludes reconditioningunder Section 801(b) of the FD&C Act.

Products imported from the firm(s) listed on the Red List to this import alert should remain subject to detention without physicalexamination until an FDA inspection is completed. Firms may provide copies of inspection reports for inspections performed by thirdparties only to assist FDA in prioritizing inspection requests.

Import Alert 9932

FDA Home3 Import Program4 Import Alerts Imports Alerts by Number Import Alert

http://www.fda.gov/default.htm
http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
http://www.addthis.com/bookmark.php
http://www.fda.gov/default.htm
http://www.fda.gov/ForIndustry/ImportProgram/default.htm
http://www.accessdata.fda.gov/cms_ia/default.html
http://www.accessdata.fda.gov/cms_ia/ialist.html
Page 2: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Agrisan Specialty Chemical and Pharmaceutical, Maher Industr Date Published : 12/16/2014

Baoying County Fukang Medical Appliance Co., Ltd. Date Published : 09/20/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 12/16/201460 Human and Animal Drugs Date Published: 12/16/201461 Human and Animal Drugs Date Published: 12/16/201462 Human and Animal Drugs Date Published: 12/16/201463 Human and Animal Drugs Date Published: 12/16/201464 Human and Animal Drugs Date Published: 12/16/201465 Human and Animal Drugs Date Published: 12/16/201466 Human and Animal Drugs Date Published: 12/16/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 09/20/2016

56 Antibiotics (Human/Animal) Date Published: 09/20/2016

60 Human and Animal Drugs Date Published: 09/20/2016

61 Human and Animal Drugs Date Published: 09/20/2016

62 Human and Animal Drugs Date Published: 09/20/2016

A manufacturer wishing to schedule an FDA inspection or to provide a copy of an inspection report conducted by a third party,should do so by submitting a request or documentation to the following address:

Food and Drug Administration Division of Import Operations12420 Parklawn DriveELEM 3109Rockville, MD 20857Or via email: [email protected]

Product Description:PRODUCT:

See Red List

PRODUCT CODE:

See Red List

PROBLEM:

Inspection Refusal

Charge:(If the article is from a firm that has refused establishment inspection which, combined with other evidence, provides anappearance that the article has been manufactured, processed, or packed under insanitary conditions): "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured,processed, or packed under insanitary conditions."

OASIS CHARGE CODE: REFUSE EI

(If the article is a drug that has been manufactured, processed, packed, or held in any factory, warehouse, or establishment andthe owner, operator, or ***agent*** of such factory, warehouse, or establishment delays, denies, or limits an inspection, orrefuses to permit entry or inspection): "The article of drug is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to beadulterated under section 501(j) of the FD&C Act."

OASIS CHARGE CODE: DRG REF EI

(If the article is food from a foreign establishment that refuses to permit entry of United States inspectors or other individuals, dulydesignated by the Secretary, to inspect their facilities):"The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishmentof which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of UnitedStates inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or otherestablishment."

OASIS CHARGE CODE: 807REFUSAL

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert(a.k.a. Red List)

CANADA451 Smith Street , Arthur, Ontario CANADA

CHINATrade of , Su Zhongbeilu; Baoyingxian , Yangzhou, Jiangsu CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Page 3: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Beijing Shunxin Meihua Biotechnical Co., Ltd. Date Published : 07/22/2014

Beijing Taiyang Pharmaceutical Industry Co Ltd Date Published : 04/28/2016

Beyond Technology Corporation Nanchang Date Published : 04/19/2016

62 Human and Animal Drugs Date Published: 09/20/2016

63 Human and Animal Drugs Date Published: 09/20/2016

64 Human and Animal Drugs Date Published: 09/20/2016

65 Human and Animal Drugs Date Published: 09/20/2016

66 Human and Animal Drugs Date Published: 09/20/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/22/2014

56 Antibiotics (Human/Animal) Date Published: 07/22/2014

60 Human and Animal Drugs Date Published: 07/22/2014

61 Human and Animal Drugs Date Published: 07/22/2014

62 Human and Animal Drugs Date Published: 07/22/2014

63 Human and Animal Drugs Date Published: 07/22/2014

64 Human and Animal Drugs Date Published: 07/22/2014

65 Human and Animal Drugs Date Published: 07/22/2014

66 Human and Animal Drugs Date Published: 07/22/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 04/28/2016

56 Antibiotics (Human/Animal) Date Published: 04/28/2016

60 Human and Animal Drugs Date Published: 04/28/2016

61 Human and Animal Drugs Date Published: 04/28/2016

62 Human and Animal Drugs Date Published: 04/28/2016

63 Human and Animal Drugs Date Published: 04/28/2016

64 Human and Animal Drugs Date Published: 04/28/2016

65 Human and Animal Drugs Date Published: 04/28/2016

66 Human and Animal Drugs Date Published: 04/28/2016

53 I 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)Date Published: 04/19/2016

53 I 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 04/19/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 04/19/2016

56 Antibiotics (Human/Animal) Date Published: 04/19/2016

60 Human and Animal Drugs Date Published: 04/19/2016

61 Human and Animal Drugs Date Published: 04/19/2016

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

No 7 Fuqiandongjie , Shunyi District , Shunyiqu, Beijingshi CHINA

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

Notes:All drug products; Firm refused FDA inspection

NO 1 Shuangqiao (E) Road , Chaoyang, Beijing CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

NO 162 Kejidadao , Qingshanhu , Nanchang, Jiangxi CHINA

Desc:All Drug and Drug Products Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Desc:All Drug and Drug Products Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject to

Page 4: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Chaozhou Chaoan Sauce Stuff Provinsion Fty Date Published : 11/20/2014

62 Human and Animal Drugs Date Published: 04/19/2016

63 Human and Animal Drugs Date Published: 04/19/2016

64 Human and Animal Drugs Date Published: 04/19/2016

65 Human and Animal Drugs Date Published: 04/19/2016

66 Human and Animal Drugs Date Published: 04/19/2016

02 Whole Grain/Milled Grain Prod/Starch Date Published: 11/20/2014

03 Bakery Prod/Dough/Mix/Icing Date Published: 11/20/2014

04 Macaroni/Noodle Prod Date Published: 11/20/2014

05 Cereal Prep/Breakfast Food Date Published: 11/20/2014

07 Snack Food Item Date Published: 11/20/2014

09 Milk/Butter/Dried Milk Prod Date Published: 11/20/2014

12 Cheese/Cheese Prod Date Published: 11/20/2014

13 Ice Cream Prod Date Published: 11/20/2014

14 Filled Milk/Imit Milk Prod Date Published: 11/20/2014

15 Egg/Egg Prod Date Published: 11/20/2014

16 Fishery/Seafood Prod Date Published: 11/20/2014

17 Meat, Meat Products and Poultry Date Published: 11/20/2014

18 Vegetable Protein Prod Date Published: 11/20/2014

20 Fruit/Fruit Prod Date Published: 11/20/2014

21 Fruit/Fruit Prod Date Published: 11/20/2014

22 Fruit/Fruit Prod Date Published: 11/20/2014

23 Nuts/Edible Seed Date Published: 11/20/2014

24 Vegetables/Vegetable Products Date Published: 11/20/2014

25 Vegetables/Vegetable Products Date Published: 11/20/2014

26 Vegetable Oils Date Published: 11/20/2014

27 Dressing/Condiment Date Published: 11/20/2014

28 Spices, Flavors And Salts Date Published: 11/20/2014

29 Soft Drink/Water Date Published: 11/20/2014

30 Beverage Bases/Conc/Nectar Date Published: 11/20/2014

31 Coffee/Tea Date Published: 11/20/2014

32 Alcoholic Beverage Date Published: 11/20/2014

33 Candy W/O Choc/Special/Chew Gum Date Published: 11/20/2014

34 Choc/Cocoa Prod Date Published: 11/20/2014

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Notes:All Drug and Drug Products;For product codes 53I[][]01 and 53I[][]99, only products found to be drug products are subject toDWPE under this listing.

Caitang,chaoan County , Chaozhou, Yandongsheng CHINA

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Page 5: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Guangxi Jisheng Foods Inc Date Published : 10/04/2013

34 Choc/Cocoa Prod Date Published: 11/20/2014

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 11/20/2014

36 Food Sweeteners (Nutritive) Date Published: 11/20/2014

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 11/20/2014

38 Soup Date Published: 11/20/2014

39 Prep Salad Prod Date Published: 11/20/2014

40 A Baked Goods (Baby) Date Published: 11/20/2014

40 B Cereal (Baby) Date Published: 11/20/2014

40 D Veg (Baby) Date Published: 11/20/2014

40 E Fruit/Juice/Drink (Baby) Date Published: 11/20/2014

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 11/20/2014

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 11/20/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 11/20/2014

40 I FishSeafood Prod (Baby) Date Published: 11/20/2014

40 J Egg Prod (Baby) Date Published: 11/20/2014

40 K Pudding/Custard (Baby) Date Published: 11/20/2014

40 L Soups/Soup Mix (Baby) Date Published: 11/20/2014

40 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 11/20/2014

40 X Market Basket Sampling Date Published: 11/20/2014

40 Y Baby Food N.E.C. Date Published: 11/20/2014

41 Dietary Conv Food/Meal Replacements Date Published: 11/20/2014

52 B 06 Corn Husks (Food Related) Date Published: 11/20/2014

52 B 07 Snail Shells (Food Related) Date Published: 11/20/2014

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 11/20/2014

52 B 12 Bird's Nest Date Published: 11/20/2014

52 D Live Animals Date Published: 11/20/2014

02 Whole Grain/Milled Grain Prod/Starch Date Published: 10/04/201303 Bakery Prod/Dough/Mix/Icing Date Published: 10/04/201304 Macaroni/Noodle Prod Date Published: 10/04/201305 Cereal Prep/Breakfast Food Date Published: 10/04/201307 Snack Food Item Date Published: 10/04/201309 Milk/Butter/Dried Milk Prod Date Published: 10/04/201312 Cheese/Cheese Prod Date Published: 10/04/201313 Ice Cream Prod Date Published: 10/04/201314 Filled Milk/Imit Milk Prod Date Published: 10/04/201315 Egg/Egg Prod Date Published: 10/04/201316 Fishery/Seafood Prod Date Published: 10/04/201317 Meat, Meat Products and Poultry Date Published: 10/04/201318 Vegetable Protein Prod Date Published: 10/04/201320 Fruit/Fruit Prod Date Published: 10/04/201321 Fruit/Fruit Prod Date Published: 10/04/201322 Fruit/Fruit Prod Date Published: 10/04/201323 Nuts/Edible Seed Date Published: 10/04/2013

24 Vegetables/Vegetable Products Date Published: 10/04/2013

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

Notes:All Food Products;Problem(s): Inspection Refusal

5 Latitude Four Road , Liujing Industrial Park, Liujing , Hengxian County, Guangxi CHINA

Page 6: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Guangzhou Baiyunshan Guanghua Pharmacy Co. Ltd. Date Published : 08/22/2016

Hangzhou Hetd Industry Co., Ltd. Date Published : 05/01/2013

24 Vegetables/Vegetable Products Date Published: 10/04/201325 Vegetables/Vegetable Products Date Published: 10/04/201326 Vegetable Oils Date Published: 10/04/201327 Dressing/Condiment Date Published: 10/04/201328 Spices, Flavors And Salts Date Published: 10/04/201329 Soft Drink/Water Date Published: 10/04/201330 Beverage Bases/Conc/Nectar Date Published: 10/04/201331 Coffee/Tea Date Published: 10/04/201332 Alcoholic Beverage Date Published: 10/04/201333 Candy W/O Choc/Special/Chew Gum Date Published: 10/04/201334 Choc/Cocoa Prod Date Published: 10/04/201335 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 10/04/201336 Food Sweeteners (Nutritive) Date Published: 10/04/201337 Mult Food Dinner/Grav/Sauce/Special Date Published: 10/04/201338 Soup Date Published: 10/04/201339 Prep Salad Prod Date Published: 10/04/201340 A Baked Goods (Baby) Date Published: 10/04/201340 B Cereal (Baby) Date Published: 10/04/201340 D Veg (Baby) Date Published: 10/04/201340 E Fruit/Juice/Drink (Baby) Date Published: 10/04/201340 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 10/04/201340 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 10/04/201340 H High Meat Dinner/Cheese Food (Baby) Date Published: 10/04/201340 I FishSeafood Prod (Baby) Date Published: 10/04/201340 J Egg Prod (Baby) Date Published: 10/04/201340 K Pudding/Custard (Baby) Date Published: 10/04/201340 L Soups/Soup Mix (Baby) Date Published: 10/04/201340 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 10/04/201340 X Market Basket Sampling Date Published: 10/04/201340 Y Baby Food N.E.C. Date Published: 10/04/201341 Dietary Conv Food/Meal Replacements Date Published: 10/04/201352 B 06 Corn Husks (Food Related) Date Published: 10/04/201352 B 07 Snail Shells (Food Related) Date Published: 10/04/201352 B 08 Sausage Casings, Artificial (Food Related) Date Published: 10/04/201352 B 12 Bird's Nest Date Published: 10/04/201352 D Live Animals Date Published: 10/04/2013

54 Vit/Min/Prot/Unconv Diet(Human/Animal) Date Published: 08/22/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/22/2016

56 Antibiotics (Human/Animal) Date Published: 08/22/2016

60 Human and Animal Drugs Date Published: 08/22/2016

61 Human and Animal Drugs Date Published: 08/22/2016

62 Human and Animal Drugs Date Published: 08/22/2016

63 Human and Animal Drugs Date Published: 08/22/2016

64 Human and Animal Drugs Date Published: 08/22/2016

65 Human and Animal Drugs Date Published: 08/22/2016

66 Human and Animal Drugs Date Published: 08/22/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 05/01/201360 Human and Animal Drugs Date Published: 05/01/201361 Human and Animal Drugs Date Published: 05/01/201362 Human and Animal Drugs Date Published: 05/01/201363 Human and Animal Drugs Date Published: 05/01/201364 Human and Animal Drugs Date Published: 05/01/201365 Human and Animal Drugs Date Published: 05/01/201366 Human and Animal Drugs Date Published: 05/01/2013

NO. 1 16 Nanshi Road , Haizhu District , Guangzhou, CHINA

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

Notes:All Drug, Drug Products, and Dietary Supplements

8, Xiyuan Yi Road, Sandun , Hangzhou, Zhejiang CHINA

Page 7: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Hangzhou Hetd Industry Co., Ltd. Date Published : 05/01/2013

Jiangsu Longliqi Bioscience Co Ltd. Date Published : 10/20/2016

Jiangxi Yuneng Pharmaceutical Co., Ltd. Date Published : 04/08/2016

MC Group Development Ltd. Date Published : 07/12/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 05/01/201360 Human and Animal Drugs Date Published: 05/01/201361 Human and Animal Drugs Date Published: 05/01/201362 Human and Animal Drugs Date Published: 05/01/201363 Human and Animal Drugs Date Published: 05/01/201364 Human and Animal Drugs Date Published: 05/01/201365 Human and Animal Drugs Date Published: 05/01/201366 Human and Animal Drugs Date Published: 05/01/2013

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 10/20/2016

56 Antibiotics (Human/Animal) Date Published: 10/20/2016

60 Human and Animal Drugs Date Published: 10/20/2016

61 Human and Animal Drugs Date Published: 10/20/2016

62 Human and Animal Drugs Date Published: 10/20/2016

63 Human and Animal Drugs Date Published: 10/20/2016

64 Human and Animal Drugs Date Published: 10/20/2016

65 Human and Animal Drugs Date Published: 10/20/2016

66 Human and Animal Drugs Date Published: 10/20/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 04/08/2016

56 Antibiotics (Human/Animal) Date Published: 04/08/2016

60 Human and Animal Drugs Date Published: 04/08/2016

61 Human and Animal Drugs Date Published: 04/08/2016

62 Human and Animal Drugs Date Published: 04/08/2016

63 Human and Animal Drugs Date Published: 04/08/2016

64 Human and Animal Drugs Date Published: 04/08/2016

65 Human and Animal Drugs Date Published: 04/08/2016

66 Human and Animal Drugs Date Published: 04/08/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/12/2016

56 Antibiotics (Human/Animal) Date Published: 07/12/2016

60 Human and Animal Drugs Date Published: 07/12/2016

61 Human and Animal Drugs Date Published: 07/12/2016

62 Human and Animal Drugs Date Published: 07/12/2016

63 Human and Animal Drugs Date Published: 07/12/2016

64 Human and Animal Drugs Date Published: 07/12/2016

65 Human and Animal Drugs Date Published: 07/12/2016

66 Human and Animal Drugs Date Published: 07/12/2016

8, Xiyuan Yi Road, Sandun , Hangzhou, Zhejiang CHINA

Longliqi Biological Ind. Park , Changnan Village, Xinzhuang , Changshu, CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

HiTech Industrial Development District , Jian City, Jiangxi CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

1095 Duanmei Rd , Yingzhou District , Ningbo, Zhejiang CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Page 8: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Nanjing County Yideli Canned Food Co., Ltd Date Published : 09/06/2010

02 Whole Grain/Milled Grain Prod/Starch Date Published: 09/06/2010

03 Bakery Prod/Dough/Mix/Icing Date Published: 09/06/2010

04 Macaroni/Noodle Prod Date Published: 09/06/2010

05 Cereal Prep/Breakfast Food Date Published: 09/06/2010

07 Snack Food Item Date Published: 09/06/2010

09 Milk/Butter/Dried Milk Prod Date Published: 09/06/2010

12 Cheese/Cheese Prod Date Published: 09/06/2010

13 Ice Cream Prod Date Published: 09/06/2010

14 Filled Milk/Imit Milk Prod Date Published: 09/06/2010

15 Egg/Egg Prod Date Published: 09/06/2010

16 Fishery/Seafood Prod Date Published: 09/06/2010

17 Meat, Meat Products and Poultry Date Published: 09/06/2010

18 Vegetable Protein Prod Date Published: 09/06/2010

20 Fruit/Fruit Prod Date Published: 09/06/2010

21 Fruit/Fruit Prod Date Published: 09/06/2010

22 Fruit/Fruit Prod Date Published: 09/06/2010

23 Nuts/Edible Seed Date Published: 09/06/2010

24 Vegetables/Vegetable Products Date Published: 09/06/2010

25 Vegetables/Vegetable Products Date Published: 09/06/2010

26 Vegetable Oils Date Published: 09/06/2010

27 Dressing/Condiment Date Published: 09/06/2010

28 Spices, Flavors And Salts Date Published: 09/06/2010

29 Soft Drink/Water Date Published: 09/06/2010

30 Beverage Bases/Conc/Nectar Date Published: 09/06/2010

31 Coffee/Tea Date Published: 09/06/2010

32 Alcoholic Beverage Date Published: 09/06/2010

33 Candy W/O Choc/Special/Chew Gum Date Published: 09/06/2010

34 Choc/Cocoa Prod Date Published: 09/06/2010

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 09/06/2010

36 Food Sweeteners (Nutritive) Date Published: 09/06/2010

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 09/06/2010

38 Soup Date Published: 09/06/2010

39 Prep Salad Prod Date Published: 09/06/2010

40 A Baked Goods (Baby) Date Published: 09/06/2010

40 B Cereal (Baby) Date Published: 09/06/2010

40 C Formula Prod (Baby) Date Published: 09/06/2010

Mashan, Longshan Town , Nanjing County , Zhangzhou, Cn35 CHINA

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Page 9: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Ningbo Gooey BioTechnology Co., Ltd. Date Published : 06/17/2016

Qingdao Jinfeng Pharmaceutical Co., Ltd Date Published : 10/21/2016

40 D Veg (Baby) Date Published: 09/06/2010

40 E Fruit/Juice/Drink (Baby) Date Published: 09/06/2010

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 09/06/2010

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 09/06/2010

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 09/06/2010

40 I FishSeafood Prod (Baby) Date Published: 09/06/2010

40 J Egg Prod (Baby) Date Published: 09/06/2010

40 K Pudding/Custard (Baby) Date Published: 09/06/2010

40 L Soups/Soup Mix (Baby) Date Published: 09/06/2010

40 M Infant Formula Raw Material Date Published: 09/06/2010

40 X Market Basket Sampling Date Published: 09/06/2010

40 Y Baby Food N.E.C. Date Published: 09/06/2010

41 Dietary Conv Food/Meal Replacements Date Published: 09/06/2010

52 B 06 Corn Husks (Food Related) Date Published: 09/06/2010

52 B 07 Snail Shells (Food Related) Date Published: 09/06/2010

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 09/06/2010

52 D Live Animals Date Published: 09/06/2010

52 E Infant Food Items Date Published: 09/06/2010

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 06/17/2016

56 Antibiotics (Human/Animal) Date Published: 06/17/2016

60 Human and Animal Drugs Date Published: 06/17/2016

61 Human and Animal Drugs Date Published: 06/17/2016

62 Human and Animal Drugs Date Published: 06/17/2016

63 Human and Animal Drugs Date Published: 06/17/2016

64 Human and Animal Drugs Date Published: 06/17/2016

65 Human and Animal Drugs Date Published: 06/17/2016

66 Human and Animal Drugs Date Published: 06/17/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 10/21/2016

56 Antibiotics (Human/Animal) Date Published: 10/21/2016

60 Human and Animal Drugs Date Published: 10/21/2016

61 Human and Animal Drugs Date Published: 10/21/2016

62 Human and Animal Drugs Date Published: 10/21/2016

63 Human and Animal Drugs Date Published: 10/21/2016

64 Human and Animal Drugs Date Published: 10/21/2016

65 Human and Animal Drugs Date Published: 10/21/2016

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

Notes:Manufacturer; Date of Inspection Refusal: 7/26/10

NO. 166 Xinghailu , Ninghaixian , Ningbo, Zhejiang CHINA

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

NO 3 Yantai Road , Laixi, Qingdao CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Page 10: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Shandong Xinhua & Longxin Chemical Co. Ltd. Date Published : 05/25/2016

Shanghai Chuangi Food Co. Ltd. Date Published : 10/12/2010

65 Human and Animal Drugs Date Published: 10/21/2016

66 Human and Animal Drugs Date Published: 10/21/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 05/25/2016

56 Antibiotics (Human/Animal) Date Published: 05/25/2016

60 Human and Animal Drugs Date Published: 05/25/2016

61 Human and Animal Drugs Date Published: 05/25/2016

62 Human and Animal Drugs Date Published: 05/25/2016

63 Human and Animal Drugs Date Published: 05/25/2016

64 Human and Animal Drugs Date Published: 05/25/2016

65 Human and Animal Drugs Date Published: 05/25/2016

66 Human and Animal Drugs Date Published: 05/25/2016

02 Whole Grain/Milled Grain Prod/Starch Date Published: 10/12/2010

03 Bakery Prod/Dough/Mix/Icing Date Published: 10/12/2010

04 Macaroni/Noodle Prod Date Published: 10/12/2010

05 Cereal Prep/Breakfast Food Date Published: 10/12/2010

07 Snack Food Item Date Published: 10/12/2010

09 Milk/Butter/Dried Milk Prod Date Published: 10/12/2010

12 Cheese/Cheese Prod Date Published: 10/12/2010

13 Ice Cream Prod Date Published: 10/12/2010

14 Filled Milk/Imit Milk Prod Date Published: 10/12/2010

15 Egg/Egg Prod Date Published: 10/12/2010

16 Fishery/Seafood Prod Date Published: 10/12/2010

17 Meat, Meat Products and Poultry Date Published: 10/12/2010

18 Vegetable Protein Prod Date Published: 10/12/2010

20 Fruit/Fruit Prod Date Published: 10/12/2010

21 Fruit/Fruit Prod Date Published: 10/12/2010

22 Fruit/Fruit Prod Date Published: 10/12/2010

23 Nuts/Edible Seed Date Published: 10/12/2010

24 Vegetables/Vegetable Products Date Published: 10/12/2010

25 Vegetables/Vegetable Products Date Published: 10/12/2010

26 Vegetable Oils Date Published: 10/12/2010

27 Dressing/Condiment Date Published: 10/12/2010

28 Spices, Flavors And Salts Date Published: 10/12/2010

29 Soft Drink/Water Date Published: 10/12/2010

30 Beverage Bases/Conc/Nectar Date Published: 10/12/2010

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

NO. 299 Yixi Road , Linzi District , Zibo, Shandong CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

138 Kangjian Road , Xuhui District , Shanghai, CHINA

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Page 11: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Shanghai Chuanqi Food Co., Ltd. Date Published : 10/12/2010

30 Beverage Bases/Conc/Nectar Date Published: 10/12/2010

31 Coffee/Tea Date Published: 10/12/2010

32 Alcoholic Beverage Date Published: 10/12/2010

33 Candy W/O Choc/Special/Chew Gum Date Published: 10/12/2010

34 Choc/Cocoa Prod Date Published: 10/12/2010

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 10/12/2010

36 Food Sweeteners (Nutritive) Date Published: 10/12/2010

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 10/12/2010

38 Soup Date Published: 10/12/2010

39 Prep Salad Prod Date Published: 10/12/2010

40 A Baked Goods (Baby) Date Published: 10/12/2010

40 B Cereal (Baby) Date Published: 10/12/2010

40 C Formula Prod (Baby) Date Published: 10/12/2010

40 D Veg (Baby) Date Published: 10/12/2010

40 E Fruit/Juice/Drink (Baby) Date Published: 10/12/2010

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 10/12/2010

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 10/12/2010

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 10/12/2010

40 I FishSeafood Prod (Baby) Date Published: 10/12/2010

40 J Egg Prod (Baby) Date Published: 10/12/2010

40 K Pudding/Custard (Baby) Date Published: 10/12/2010

40 L Soups/Soup Mix (Baby) Date Published: 10/12/2010

40 M Infant Formula Raw Material Date Published: 10/12/2010

40 X Market Basket Sampling Date Published: 10/12/2010

40 Y Baby Food N.E.C. Date Published: 10/12/2010

41 Dietary Conv Food/Meal Replacements Date Published: 10/12/2010

52 B 06 Corn Husks (Food Related) Date Published: 10/12/2010

52 B 07 Snail Shells (Food Related) Date Published: 10/12/2010

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 10/12/2010

52 D Live Animals Date Published: 10/12/2010

52 E Infant Food Items Date Published: 10/12/2010

02 Whole Grain/Milled Grain Prod/Starch Date Published: 10/12/2010

03 Bakery Prod/Dough/Mix/Icing Date Published: 10/12/2010

04 Macaroni/Noodle Prod Date Published: 10/12/2010

05 Cereal Prep/Breakfast Food Date Published: 10/12/2010

07 Snack Food Item Date Published: 10/12/2010

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

No. 96 Jianlu Road , Shanghai, CN31 CHINA

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Page 12: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

09 Milk/Butter/Dried Milk Prod Date Published: 10/12/2010

12 Cheese/Cheese Prod Date Published: 10/12/2010

13 Ice Cream Prod Date Published: 10/12/2010

14 Filled Milk/Imit Milk Prod Date Published: 10/12/2010

15 Egg/Egg Prod Date Published: 10/12/2010

16 Fishery/Seafood Prod Date Published: 10/12/2010

17 Meat, Meat Products and Poultry Date Published: 10/12/2010

18 Vegetable Protein Prod Date Published: 10/12/2010

20 Fruit/Fruit Prod Date Published: 10/12/2010

21 Fruit/Fruit Prod Date Published: 10/12/2010

22 Fruit/Fruit Prod Date Published: 10/12/2010

23 Nuts/Edible Seed Date Published: 10/12/2010

24 Vegetables/Vegetable Products Date Published: 10/12/2010

25 Vegetables/Vegetable Products Date Published: 10/12/2010

26 Vegetable Oils Date Published: 10/12/2010

27 Dressing/Condiment Date Published: 10/12/2010

28 Spices, Flavors And Salts Date Published: 10/12/2010

29 Soft Drink/Water Date Published: 10/12/2010

30 Beverage Bases/Conc/Nectar Date Published: 10/12/2010

31 Coffee/Tea Date Published: 10/12/2010

32 Alcoholic Beverage Date Published: 10/12/2010

33 Candy W/O Choc/Special/Chew Gum Date Published: 10/12/2010

34 Choc/Cocoa Prod Date Published: 10/12/2010

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 10/12/2010

36 Food Sweeteners (Nutritive) Date Published: 10/12/2010

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 10/12/2010

38 Soup Date Published: 10/12/2010

39 Prep Salad Prod Date Published: 10/12/2010

40 A Baked Goods (Baby) Date Published: 10/12/2010

40 B Cereal (Baby) Date Published: 10/12/2010

40 C Formula Prod (Baby) Date Published: 10/12/2010

40 D Veg (Baby) Date Published: 10/12/2010

40 E Fruit/Juice/Drink (Baby) Date Published: 10/12/2010

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 10/12/2010

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 10/12/2010

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 10/12/2010

40 I FishSeafood Prod (Baby) Date Published: 10/12/2010

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Page 13: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Shanghai Wei Chuan Foods Industrial Co., Ltd. Date Published : 11/21/2014

40 I FishSeafood Prod (Baby) Date Published: 10/12/2010

40 J Egg Prod (Baby) Date Published: 10/12/2010

40 K Pudding/Custard (Baby) Date Published: 10/12/2010

40 L Soups/Soup Mix (Baby) Date Published: 10/12/2010

40 M Infant Formula Raw Material Date Published: 10/12/2010

40 X Market Basket Sampling Date Published: 10/12/2010

40 Y Baby Food N.E.C. Date Published: 10/12/2010

41 Dietary Conv Food/Meal Replacements Date Published: 10/12/2010

52 B 06 Corn Husks (Food Related) Date Published: 10/12/2010

52 B 07 Snail Shells (Food Related) Date Published: 10/12/2010

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 10/12/2010

52 D Live Animals Date Published: 10/12/2010

52 E Infant Food Items Date Published: 10/12/2010

02 Whole Grain/Milled Grain Prod/Starch Date Published: 11/21/2014

03 Bakery Prod/Dough/Mix/Icing Date Published: 11/21/2014

04 Macaroni/Noodle Prod Date Published: 11/21/2014

05 Cereal Prep/Breakfast Food Date Published: 11/21/2014

07 Snack Food Item Date Published: 11/21/2014

09 Milk/Butter/Dried Milk Prod Date Published: 11/21/2014

12 Cheese/Cheese Prod Date Published: 11/21/2014

13 Ice Cream Prod Date Published: 11/21/2014

14 Filled Milk/Imit Milk Prod Date Published: 11/21/2014

15 Egg/Egg Prod Date Published: 11/21/2014

16 Fishery/Seafood Prod Date Published: 11/21/2014

17 Meat, Meat Products and Poultry Date Published: 11/21/2014

18 Vegetable Protein Prod Date Published: 11/21/2014

20 Fruit/Fruit Prod Date Published: 11/21/2014

21 Fruit/Fruit Prod Date Published: 11/21/2014

22 Fruit/Fruit Prod Date Published: 11/21/2014

23 Nuts/Edible Seed Date Published: 11/21/2014

24 Vegetables/Vegetable Products Date Published: 11/21/2014

25 Vegetables/Vegetable Products Date Published: 11/21/2014

26 Vegetable Oils Date Published: 11/21/2014

27 Dressing/Condiment Date Published: 11/21/2014

28 Spices, Flavors And Salts Date Published: 11/21/2014

29 Soft Drink/Water Date Published: 11/21/2014

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

Notes:All Food Products; Manuafacturer; Date of Inspection refusal: 9/16/10

No.88, Cao Xin Rd., Caowang Town , Development Area, Jiading District , Shanghai, Shanghai CHINA

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Page 14: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Shenzhen Happy Pharmaceuticals Ltd. Date Published : 10/14/2016

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 11/21/2014

38 Soup Date Published: 11/21/2014

39 Prep Salad Prod Date Published: 11/21/2014

40 A Baked Goods (Baby) Date Published: 11/21/2014

40 B Cereal (Baby) Date Published: 11/21/2014

40 D Veg (Baby) Date Published: 11/21/2014

40 E Fruit/Juice/Drink (Baby) Date Published: 11/21/2014

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 11/21/2014

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 11/21/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 11/21/2014

40 I FishSeafood Prod (Baby) Date Published: 11/21/2014

40 J Egg Prod (Baby) Date Published: 11/21/2014

40 K Pudding/Custard (Baby) Date Published: 11/21/2014

40 L Soups/Soup Mix (Baby) Date Published: 11/21/2014

40 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 11/21/2014

40 X Market Basket Sampling Date Published: 11/21/2014

40 Y Baby Food N.E.C. Date Published: 11/21/2014

41 Dietary Conv Food/Meal Replacements Date Published: 11/21/2014

52 B 06 Corn Husks (Food Related) Date Published: 11/21/2014

52 B 07 Snail Shells (Food Related) Date Published: 11/21/2014

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 11/21/2014

52 B 12 Bird's Nest Date Published: 11/21/2014

52 D Live Animals Date Published: 11/21/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 10/14/2016

56 Antibiotics (Human/Animal) Date Published: 10/14/2016

60 Human and Animal Drugs Date Published: 10/14/2016

61 Human and Animal Drugs Date Published: 10/14/2016

62 Human and Animal Drugs Date Published: 10/14/2016

63 Human and Animal Drugs Date Published: 10/14/2016

30 Beverage Bases/Conc/Nectar Date Published: 11/21/2014

31 Coffee/Tea Date Published: 11/21/2014

32 Alcoholic Beverage Date Published: 11/21/2014

33 Candy W/O Choc/Special/Chew Gum Date Published: 11/21/2014

34 Choc/Cocoa Prod Date Published: 11/21/2014

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 11/21/2014

36 Food Sweeteners (Nutritive) Date Published: 11/21/2014

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

NO. 8 Xingfu Road Gudi , Industrial Zone , Weifang, Shandong CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Page 15: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Taisan City Chemical Pharmaceutical Co., Ltd. Date Published : 10/19/2015

Taizhou Xinyou Pharmaceutical & Chemical Co., Ltd. Date Published : 01/25/2016

Tianjin Zhongan Pharmaceutical Co., Ltd. Date Published : 02/09/2016

63 Human and Animal Drugs Date Published: 10/14/2016

64 Human and Animal Drugs Date Published: 10/14/2016

65 Human and Animal Drugs Date Published: 10/14/2016

66 Human and Animal Drugs Date Published: 10/14/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 10/19/2015

56 Antibiotics (Human/Animal) Date Published: 10/19/2015

60 Human and Animal Drugs Date Published: 10/19/2015

61 Human and Animal Drugs Date Published: 10/19/2015

62 Human and Animal Drugs Date Published: 10/19/2015

63 Human and Animal Drugs Date Published: 10/19/2015

64 Human and Animal Drugs Date Published: 10/19/2015

65 Human and Animal Drugs Date Published: 10/19/2015

66 Human and Animal Drugs Date Published: 10/19/2015

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 01/25/2016

56 Antibiotics (Human/Animal) Date Published: 01/25/2016

60 Human and Animal Drugs Date Published: 01/25/2016

61 Human and Animal Drugs Date Published: 01/25/2016

62 Human and Animal Drugs Date Published: 01/25/2016

63 Human and Animal Drugs Date Published: 01/25/2016

64 Human and Animal Drugs Date Published: 01/25/2016

65 Human and Animal Drugs Date Published: 01/25/2016

66 Human and Animal Drugs Date Published: 01/25/2016

02 Whole Grain/Milled Grain Prod/Starch Date Published: 02/09/201603 Bakery Prod/Dough/Mix/Icing Date Published: 02/09/201604 Macaroni/Noodle Prod Date Published: 02/09/201605 Cereal Prep/Breakfast Food Date Published: 02/09/201607 Snack Food Item Date Published: 02/09/201609 Milk/Butter/Dried Milk Prod Date Published: 02/09/201612 Cheese/Cheese Prod Date Published: 02/09/201613 Ice Cream Prod Date Published: 02/09/201614 Filled Milk/Imit Milk Prod Date Published: 02/09/201615 Egg/Egg Prod Date Published: 02/09/201616 Fishery/Seafood Prod Date Published: 02/09/201617 Meat, Meat Products and Poultry Date Published: 02/09/201618 Vegetable Protein Prod Date Published: 02/09/201620 Fruit/Fruit Prod Date Published: 02/09/201621 Fruit/Fruit Prod Date Published: 02/09/201622 Fruit/Fruit Prod Date Published: 02/09/201623 Nuts/Edible Seed Date Published: 02/09/201624 Vegetables/Vegetable Products Date Published: 02/09/201625 Vegetables/Vegetable Products Date Published: 02/09/201626 Vegetable Oils Date Published: 02/09/2016

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

No. 98 Longzhou Road , Taicheng Town , Taishan City , Guangdong CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

NO. 258 Jiaojiang , Taizhou, Zhejiang CHINA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Xiqing , 188 Fukang Road , Tianjin, Tianjin CHINA

Page 16: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Wellable Group Marine Biological & Chemical Co., LTD Date Published : 04/09/2014

27 Dressing/Condiment Date Published: 02/09/201628 Spices, Flavors And Salts Date Published: 02/09/201629 Soft Drink/Water Date Published: 02/09/201630 Beverage Bases/Conc/Nectar Date Published: 02/09/201631 Coffee/Tea Date Published: 02/09/201632 Alcoholic Beverage Date Published: 02/09/201633 Candy W/O Choc/Special/Chew Gum Date Published: 02/09/201634 Choc/Cocoa Prod Date Published: 02/09/201635 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 02/09/201636 Food Sweeteners (Nutritive) Date Published: 02/09/201637 Mult Food Dinner/Grav/Sauce/Special Date Published: 02/09/201638 Soup Date Published: 02/09/201639 Prep Salad Prod Date Published: 02/09/201640 A Baked Goods (Baby) Date Published: 02/09/201640 B Cereal (Baby) Date Published: 02/09/201640 D Veg (Baby) Date Published: 02/09/201640 E Fruit/Juice/Drink (Baby) Date Published: 02/09/201640 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 02/09/201640 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 02/09/201640 H High Meat Dinner/Cheese Food (Baby) Date Published: 02/09/201640 I FishSeafood Prod (Baby) Date Published: 02/09/201640 J Egg Prod (Baby) Date Published: 02/09/201640 K Pudding/Custard (Baby) Date Published: 02/09/201640 L Soups/Soup Mix (Baby) Date Published: 02/09/201640 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 02/09/201640 X Market Basket Sampling Date Published: 02/09/201640 Y Baby Food N.E.C. Date Published: 02/09/201641 Dietary Conv Food/Meal Replacements Date Published: 02/09/201642 A Whole Edible Insects (adults and immature stages) Date Published: 02/09/201642 B Milled Edible Insect Products Date Published: 02/09/201642 C Edible Insect Bars Date Published: 02/09/201642 D Edible Insect Bakery Products Date Published: 02/09/201642 E Edible Insect Candy With Chocolate Date Published: 02/09/201642 F Edible Insect Candy Without Chocolate Date Published: 02/09/201642 G Edible Insect Capsules Date Published: 02/09/201642 H Edible Insect Granola or Trail Mix Date Published: 02/09/201642 I Edible Insect Jerky Date Published: 02/09/201642 J Edible Insect Ice Cream and Related Products Date Published: 02/09/201642 K Edible Insect Oils Date Published: 02/09/201642 L Edible Insect Smoothies Date Published: 02/09/201642 M Edible Insect Soups Date Published: 02/09/201642 N Edible Insect Spreads And Pastes Date Published: 02/09/201642 O Edible Insect Beverages Date Published: 02/09/201642 P Edible Insect Protein: Simulated Meats and Tofu Date Published: 02/09/201642 Q Edible Insect Salts and Spices Date Published: 02/09/201642 R Edible Insect Products N.E.C. Date Published: 02/09/201652 B 06 Corn Husks (Food Related) Date Published: 02/09/201652 B 07 Snail Shells (Food Related) Date Published: 02/09/201652 B 08 Sausage Casings, Artificial (Food Related) Date Published: 02/09/201652 B 12 Bird's Nest Date Published: 02/09/201652 D Live Animals Date Published: 02/09/201654 Vit/Min/Prot/Unconv Diet(Human/Animal) Date Published: 02/09/201655 Pharm Necess & Ctnr For Drug/Bio Date Published: 02/09/201656 Antibiotics (Human/Animal) Date Published: 02/09/201660 Human and Animal Drugs Date Published: 02/09/201661 Human and Animal Drugs Date Published: 02/09/201662 Human and Animal Drugs Date Published: 02/09/201663 Human and Animal Drugs Date Published: 02/09/201664 Human and Animal Drugs Date Published: 02/09/201665 Human and Animal Drugs Date Published: 02/09/201666 Human and Animal Drugs Date Published: 02/09/2016

02 Whole Grain/Milled Grain Prod/Starch Date Published: 04/09/2014

03 Bakery Prod/Dough/Mix/Icing Date Published: 04/09/2014

04 Macaroni/Noodle Prod Date Published: 04/09/2014

Dabao Development Zone , Shishi, Fujian CHINA

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Page 17: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

05 Cereal Prep/Breakfast Food Date Published: 04/09/2014

07 Snack Food Item Date Published: 04/09/2014

09 Milk/Butter/Dried Milk Prod Date Published: 04/09/2014

12 Cheese/Cheese Prod Date Published: 04/09/2014

13 Ice Cream Prod Date Published: 04/09/2014

14 Filled Milk/Imit Milk Prod Date Published: 04/09/2014

15 Egg/Egg Prod Date Published: 04/09/2014

16 Fishery/Seafood Prod Date Published: 04/09/2014

17 Meat, Meat Products and Poultry Date Published: 04/09/2014

18 Vegetable Protein Prod Date Published: 04/09/2014

20 Fruit/Fruit Prod Date Published: 04/09/2014

21 Fruit/Fruit Prod Date Published: 04/09/2014

22 Fruit/Fruit Prod Date Published: 04/09/2014

23 Nuts/Edible Seed Date Published: 04/09/2014

24 Vegetables/Vegetable Products Date Published: 04/09/2014

25 Vegetables/Vegetable Products Date Published: 04/09/2014

26 Vegetable Oils Date Published: 04/09/2014

27 Dressing/Condiment Date Published: 04/09/2014

28 Spices, Flavors And Salts Date Published: 04/09/2014

29 Soft Drink/Water Date Published: 04/09/2014

30 Beverage Bases/Conc/Nectar Date Published: 04/09/2014

31 Coffee/Tea Date Published: 04/09/2014

32 Alcoholic Beverage Date Published: 04/09/2014

33 Candy W/O Choc/Special/Chew Gum Date Published: 04/09/2014

34 Choc/Cocoa Prod Date Published: 04/09/2014

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 04/09/2014

36 Food Sweeteners (Nutritive) Date Published: 04/09/2014

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 04/09/2014

38 Soup Date Published: 04/09/2014

39 Prep Salad Prod Date Published: 04/09/2014

40 A Baked Goods (Baby) Date Published: 04/09/2014

40 B Cereal (Baby) Date Published: 04/09/2014

40 D Veg (Baby) Date Published: 04/09/2014

40 E Fruit/Juice/Drink (Baby) Date Published: 04/09/2014

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 04/09/2014

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 04/09/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 04/09/2014

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

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Zhangzhou Tongfa Foods Industry Co., Ltd Date Published : 01/10/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 04/09/2014

40 I FishSeafood Prod (Baby) Date Published: 04/09/2014

40 J Egg Prod (Baby) Date Published: 04/09/2014

40 K Pudding/Custard (Baby) Date Published: 04/09/2014

40 L Soups/Soup Mix (Baby) Date Published: 04/09/2014

40 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 04/09/2014

40 X Market Basket Sampling Date Published: 04/09/2014

40 Y Baby Food N.E.C. Date Published: 04/09/2014

41 Dietary Conv Food/Meal Replacements Date Published: 04/09/2014

52 B 02 Foreign Object (Food Related) Date Published: 04/09/2014

52 B 03 Pesticides, Chemical, Etc. (Food Related) Date Published: 04/09/2014

52 B 04 Water Related To Shellfish Growing Areas (Food Related) Date Published: 04/09/2014

52 B 05 Food Packaging Material (Food Related) Date Published: 04/09/2014

52 B 06 Corn Husks (Food Related) Date Published: 04/09/2014

52 B 07 Snail Shells (Food Related) Date Published: 04/09/2014

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 04/09/2014

52 B 10 Food Manu./Processing Machinery/Parts for Home/Commercial Use Date Published: 04/09/2014

52 B 12 Bird's Nest Date Published: 04/09/2014

52 B 99 Food Related Item, N.E.C. Date Published: 04/09/2014

52 D Live Animals Date Published: 04/09/2014

52 Y Exhibit (Evidence Development) Date Published: 04/09/2014

54 Vit/Min/Prot/Unconv Diet(Human/Animal) Date Published: 04/09/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/08/2014

68 Animal Devices and Diagnostic Products Date Published: 07/08/2014

02 Whole Grain/Milled Grain Prod/Starch Date Published: 01/10/2014

03 Bakery Prod/Dough/Mix/Icing Date Published: 01/10/2014

04 Macaroni/Noodle Prod Date Published: 01/10/2014

05 Cereal Prep/Breakfast Food Date Published: 01/10/2014

07 Snack Food Item Date Published: 01/10/2014

09 Milk/Butter/Dried Milk Prod Date Published: 01/10/2014

12 Cheese/Cheese Prod Date Published: 01/10/2014

13 Ice Cream Prod Date Published: 01/10/2014

14 Filled Milk/Imit Milk Prod Date Published: 01/10/2014

15 Egg/Egg Prod Date Published: 01/10/2014

16 Fishery/Seafood Prod Date Published: 01/10/2014

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Notes:ALL food products; Problem(s): Firm refused FDA inspection

Desc:ALL PRODUCTS (including Pharmaceutical Necessities; Drugs; Biologics; Devices Human and Animal) Notes:Firm refused FDA inspection

Desc:ALL PRODUCTS (including Pharmaceutical Necessities; Drugs; Biologics; Devices Human and Animal) Notes:Firm refused FDA inspection

Hongdai Industry Zone, Jiaomei Town , Longhai , Zhangzhou, Fujian CHINA

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Page 19: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

17 Meat, Meat Products and Poultry Date Published: 01/10/2014

18 Vegetable Protein Prod Date Published: 01/10/2014

20 Fruit/Fruit Prod Date Published: 01/10/2014

21 Fruit/Fruit Prod Date Published: 01/10/2014

22 Fruit/Fruit Prod Date Published: 01/10/2014

23 Nuts/Edible Seed Date Published: 01/10/2014

24 Vegetables/Vegetable Products Date Published: 01/10/2014

25 Vegetables/Vegetable Products Date Published: 01/10/2014

26 Vegetable Oils Date Published: 01/10/2014

27 Dressing/Condiment Date Published: 01/10/2014

28 Spices, Flavors And Salts Date Published: 01/10/2014

29 Soft Drink/Water Date Published: 01/10/2014

30 Beverage Bases/Conc/Nectar Date Published: 01/10/2014

31 Coffee/Tea Date Published: 01/10/2014

32 Alcoholic Beverage Date Published: 01/10/2014

33 Candy W/O Choc/Special/Chew Gum Date Published: 01/10/2014

34 Choc/Cocoa Prod Date Published: 01/10/2014

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 01/10/2014

36 Food Sweeteners (Nutritive) Date Published: 01/10/2014

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 01/10/201438 Soup Date Published: 01/10/2014

39 Prep Salad Prod Date Published: 01/10/2014

40 A Baked Goods (Baby) Date Published: 01/10/2014

40 B Cereal (Baby) Date Published: 01/10/2014

40 D Veg (Baby) Date Published: 01/10/2014

40 E Fruit/Juice/Drink (Baby) Date Published: 01/10/2014

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 01/10/2014

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 01/10/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 01/10/2014

40 I FishSeafood Prod (Baby) Date Published: 01/10/2014

40 J Egg Prod (Baby) Date Published: 01/10/2014

40 K Pudding/Custard (Baby) Date Published: 01/10/2014

40 L Soups/Soup Mix (Baby) Date Published: 01/10/2014

40 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 01/10/2014

40 X Market Basket Sampling Date Published: 01/10/2014

40 Y Baby Food N.E.C. Date Published: 01/10/2014

41 Dietary Conv Food/Meal Replacements Date Published: 01/10/2014

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Page 20: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Zhejiang Bangli Medical Products Co., Ltd Date Published : 09/07/2016

Nan San (HK) Pharmaceutical Factory Ltd. Date Published : 07/19/2016

Sunbow Biotech Ltd Date Published : 01/27/2014

CF Pharma Ltd. Date Published : 12/08/2015

52 B 06 Corn Husks (Food Related) Date Published: 01/10/2014

52 B 07 Snail Shells (Food Related) Date Published: 01/10/2014

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 01/10/2014

52 B 12 Bird's Nest Date Published: 01/10/2014

52 D Live Animals Date Published: 01/10/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 09/07/2016

56 Antibiotics (Human/Animal) Date Published: 09/07/2016

60 Human and Animal Drugs Date Published: 09/07/2016

61 Human and Animal Drugs Date Published: 09/07/2016

62 Human and Animal Drugs Date Published: 09/07/2016

63 Human and Animal Drugs Date Published: 09/07/2016

64 Human and Animal Drugs Date Published: 09/07/2016

65 Human and Animal Drugs Date Published: 09/07/2016

66 Human and Animal Drugs Date Published: 09/07/2016

53 Cosmetics Date Published: 07/19/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/19/2016

56 Antibiotics (Human/Animal) Date Published: 07/19/2016

60 Human and Animal Drugs Date Published: 07/19/2016

61 Human and Animal Drugs Date Published: 07/19/2016

62 Human and Animal Drugs Date Published: 07/19/2016

63 Human and Animal Drugs Date Published: 07/19/2016

64 Human and Animal Drugs Date Published: 07/19/2016

65 Human and Animal Drugs Date Published: 07/19/2016

66 Human and Animal Drugs Date Published: 07/19/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 01/27/201460 Human and Animal Drugs Date Published: 01/27/201461 Human and Animal Drugs Date Published: 01/27/201462 Human and Animal Drugs Date Published: 01/27/201463 Human and Animal Drugs Date Published: 01/27/201464 Human and Animal Drugs Date Published: 01/27/201465 Human and Animal Drugs Date Published: 01/27/201466 Human and Animal Drugs Date Published: 01/27/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 12/08/2015

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Huachuan Block , 118 South of Yuegui Road , Yongkang City, Zhejiang CHINA

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

HONG KONGHoi Bun Industrial Building , 6 Wing Yip Street, Unit C1, 10/F , Kwun Tong Kowloon, Hong Kong HONG KONG

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

610 Nathan Rd , Room 131819 13F Hollywood Plaza , Mongkok Kowloon, HONG KONG

HUNGARYKen utca 5 , Budapest IX, Budapest HUNGARY

Notes:All Drug and Drug Products

Page 21: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Aadivighnesh Chemicals Pvt Ltd Date Published : 04/30/2015

Cadbury India Date Published : 10/28/2014

56 Antibiotics (Human/Animal) Date Published: 12/08/2015

60 Human and Animal Drugs Date Published: 12/08/2015

61 Human and Animal Drugs Date Published: 12/08/2015

62 Human and Animal Drugs Date Published: 12/08/2015

63 Human and Animal Drugs Date Published: 12/08/2015

64 Human and Animal Drugs Date Published: 12/08/2015

65 Human and Animal Drugs Date Published: 12/08/2015

66 Human and Animal Drugs Date Published: 12/08/2015

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 04/30/2015

56 Antibiotics (Human/Animal) Date Published: 04/30/2015

60 Human and Animal Drugs Date Published: 04/30/2015

61 Human and Animal Drugs Date Published: 04/30/2015

62 Human and Animal Drugs Date Published: 04/30/2015

63 Human and Animal Drugs Date Published: 04/30/2015

64 Human and Animal Drugs Date Published: 04/30/2015

65 Human and Animal Drugs Date Published: 04/30/2015

66 Human and Animal Drugs Date Published: 04/30/2015

02 Whole Grain/Milled Grain Prod/Starch Date Published: 10/28/2014

03 Bakery Prod/Dough/Mix/Icing Date Published: 10/28/2014

04 Macaroni/Noodle Prod Date Published: 10/28/2014

05 Cereal Prep/Breakfast Food Date Published: 10/28/2014

07 Snack Food Item Date Published: 10/28/2014

09 Milk/Butter/Dried Milk Prod Date Published: 10/28/2014

12 Cheese/Cheese Prod Date Published: 10/28/2014

13 Ice Cream Prod Date Published: 10/28/2014

14 Filled Milk/Imit Milk Prod Date Published: 10/28/2014

15 Egg/Egg Prod Date Published: 10/28/2014

16 Fishery/Seafood Prod Date Published: 10/28/2014

17 Meat, Meat Products and Poultry Date Published: 10/28/2014

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

INDIA304 B Riddhi Siddhi Complex , M.G Road Sukar Wadi, Boravali E. , Mumbai, INDIA

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

2st P0khran Road , Thane, INDIA

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Page 22: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

18 Vegetable Protein Prod Date Published: 10/28/2014

20 Fruit/Fruit Prod Date Published: 10/28/2014

21 Fruit/Fruit Prod Date Published: 10/28/2014

22 Fruit/Fruit Prod Date Published: 10/28/2014

23 Nuts/Edible Seed Date Published: 10/28/2014

24 Vegetables/Vegetable Products Date Published: 10/28/2014

25 Vegetables/Vegetable Products Date Published: 10/28/2014

26 Vegetable Oils Date Published: 10/28/2014

27 Dressing/Condiment Date Published: 10/28/2014

28 Spices, Flavors And Salts Date Published: 10/28/2014

29 Soft Drink/Water Date Published: 10/28/2014

30 Beverage Bases/Conc/Nectar Date Published: 10/28/2014

31 Coffee/Tea Date Published: 10/28/2014

32 Alcoholic Beverage Date Published: 10/28/2014

33 Candy W/O Choc/Special/Chew Gum Date Published: 10/28/2014

34 Choc/Cocoa Prod Date Published: 10/28/2014

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 10/28/2014

36 Food Sweeteners (Nutritive) Date Published: 10/28/2014

37 Mult Food Dinner/Grav/Sauce/Special Date Published: 10/28/2014

38 Soup Date Published: 10/28/2014

39 Prep Salad Prod Date Published: 10/28/2014

40 A Baked Goods (Baby) Date Published: 10/28/2014

40 B Cereal (Baby) Date Published: 10/28/2014

40 D Veg (Baby) Date Published: 10/28/2014

40 E Fruit/Juice/Drink (Baby) Date Published: 10/28/2014

40 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 10/28/2014

40 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 10/28/2014

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 10/28/2014

40 I FishSeafood Prod (Baby) Date Published: 10/28/2014

40 J Egg Prod (Baby) Date Published: 10/28/2014

40 K Pudding/Custard (Baby) Date Published: 10/28/2014

40 L Soups/Soup Mix (Baby) Date Published: 10/28/2014

40 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 10/28/2014

40 X Market Basket Sampling Date Published: 10/28/2014

40 Y Baby Food N.E.C. Date Published: 10/28/2014

41 Dietary Conv Food/Meal Replacements Date Published: 10/28/2014

52 B 06 Corn Husks (Food Related) Date Published: 10/28/2014

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Page 23: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Century Pharmaceuticals Limited Date Published : 07/28/2016

Cheryl Laboratories Pvt Ltd Date Published : 06/13/2016

Divis Pharmaceuticals Private Limited Date Published : 08/29/2016

52 B 06 Corn Husks (Food Related) Date Published: 10/28/2014

52 B 07 Snail Shells (Food Related) Date Published: 10/28/2014

52 B 08 Sausage Casings, Artificial (Food Related) Date Published: 10/28/2014

52 B 12 Bird's Nest Date Published: 10/28/2014

52 D Live Animals Date Published: 10/28/2014

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/28/2016

56 Antibiotics (Human/Animal) Date Published: 07/28/2016

60 Human and Animal Drugs Date Published: 07/28/2016

61 Human and Animal Drugs Date Published: 07/28/2016

62 Human and Animal Drugs Date Published: 07/28/2016

63 Human and Animal Drugs Date Published: 07/28/2016

64 Human and Animal Drugs Date Published: 07/28/2016

65 Human and Animal Drugs Date Published: 07/28/2016

66 Human and Animal Drugs Date Published: 07/28/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 06/13/2016

56 Antibiotics (Human/Animal) Date Published: 06/13/2016

60 Human and Animal Drugs Date Published: 06/13/2016

61 Human and Animal Drugs Date Published: 06/13/2016

62 Human and Animal Drugs Date Published: 06/13/2016

63 Human and Animal Drugs Date Published: 06/13/2016

64 Human and Animal Drugs Date Published: 06/13/2016

65 Human and Animal Drugs Date Published: 06/13/2016

66 Human and Animal Drugs Date Published: 06/13/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/29/2016

56 Antibiotics (Human/Animal) Date Published: 08/29/2016

60 Human and Animal Drugs Date Published: 08/29/2016

61 Human and Animal Drugs Date Published: 08/29/2016

62 Human and Animal Drugs Date Published: 08/29/2016

63 Human and Animal Drugs Date Published: 08/29/2016

64 Human and Animal Drugs Date Published: 08/29/2016

65 Human and Animal Drugs Date Published: 08/29/2016

66 Human and Animal Drugs Date Published: 08/29/2016

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

Notes:All Food Products

103106, GIDC, Halol , Panchamahals, Gujarat INDIA

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

A329/330, TTC INDL. AREA, MIDC MAHAPE , Navi Mumbai, Maharashtra INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Divi Towers, 7177/E/1/303, , Dharam Karan Road, Ameerpet , Hyderabad, , Andhra Pradesh INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Page 24: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Divis Pharmaceuticals Pvt Ltd Date Published : 08/30/2016

G. Amphray Laboratories Date Published : 08/30/2016

Harika Drugs Private Limited Date Published : 07/01/2016

Harika Drugs Private Limited Date Published : 07/01/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/30/2016

56 Antibiotics (Human/Animal) Date Published: 08/30/2016

60 Human and Animal Drugs Date Published: 08/30/2016

61 Human and Animal Drugs Date Published: 08/30/2016

62 Human and Animal Drugs Date Published: 08/30/2016

63 Human and Animal Drugs Date Published: 08/30/2016

64 Human and Animal Drugs Date Published: 08/30/2016

65 Human and Animal Drugs Date Published: 08/30/2016

66 Human and Animal Drugs Date Published: 08/30/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/30/2016

56 Antibiotics (Human/Animal) Date Published: 08/30/2016

60 Human and Animal Drugs Date Published: 08/30/2016

61 Human and Animal Drugs Date Published: 08/30/2016

62 Human and Animal Drugs Date Published: 08/30/2016

63 Human and Animal Drugs Date Published: 08/30/2016

64 Human and Animal Drugs Date Published: 08/30/2016

65 Human and Animal Drugs Date Published: 08/30/2016

66 Human and Animal Drugs Date Published: 08/30/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/01/2016

56 Antibiotics (Human/Animal) Date Published: 07/01/2016

60 Human and Animal Drugs Date Published: 07/01/2016

61 Human and Animal Drugs Date Published: 07/01/2016

62 Human and Animal Drugs Date Published: 07/01/2016

63 Human and Animal Drugs Date Published: 07/01/2016

64 Human and Animal Drugs Date Published: 07/01/2016

65 Human and Animal Drugs Date Published: 07/01/2016

66 Human and Animal Drugs Date Published: 07/01/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 07/01/2016

56 Antibiotics (Human/Animal) Date Published: 07/01/2016

60 Human and Animal Drugs Date Published: 07/01/2016

61 Human and Animal Drugs Date Published: 07/01/2016

62 Human and Animal Drugs Date Published: 07/01/2016

Survey No. 10 Gaddapotharam Village , Jinnaram Mandal,Medakdist, INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

10/1 Midc Industrial Area , West , Ambernath, Maharashtra INDIA

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Notes:All Drugs and Drug Products

Gummadiala Village , Medak District, Andhra Pradesh INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

5th Floor , 36/A Bhanu Enclave; Vengal Rao Nagar , Hyderabad, Telangana INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

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Laxachem Organics Private Ltd. Date Published : 08/11/2016

62 Human and Animal Drugs Date Published: 07/01/2016

63 Human and Animal Drugs Date Published: 07/01/2016

64 Human and Animal Drugs Date Published: 07/01/2016

65 Human and Animal Drugs Date Published: 07/01/2016

66 Human and Animal Drugs Date Published: 07/01/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/11/2016

56 Antibiotics (Human/Animal) Date Published: 08/11/2016

60 Human and Animal Drugs Date Published: 08/11/2016

61 Human and Animal Drugs Date Published: 08/11/2016

62 Human and Animal Drugs Date Published: 08/11/2016

63 Human and Animal Drugs Date Published: 08/11/2016

64 Human and Animal Drugs Date Published: 08/11/2016

65 Human and Animal Drugs Date Published: 08/11/2016

PHALANX LABS PRIVATE LIMITED Date Published : 06/15/2016

Silverline Chemicals Date Published : 06/29/2016

66 Human and Animal Drugs Date Published: 08/11/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 06/15/2016

56 Antibiotics (Human/Animal) Date Published: 06/15/2016

60 Human and Animal Drugs Date Published: 06/15/2016

61 Human and Animal Drugs Date Published: 06/15/2016

62 Human and Animal Drugs Date Published: 06/15/2016

63 Human and Animal Drugs Date Published: 06/15/2016

64 Human and Animal Drugs Date Published: 06/15/2016

65 Human and Animal Drugs Date Published: 06/15/2016

66 Human and Animal Drugs Date Published: 06/15/2016

53 Cosmetics Date Published: 06/29/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 06/29/2016

56 Antibiotics (Human/Animal) Date Published: 06/29/2016

60 Human and Animal Drugs Date Published: 06/29/2016

61 Human and Animal Drugs Date Published: 06/29/2016

62 Human and Animal Drugs Date Published: 06/29/2016

63 Human and Animal Drugs Date Published: 06/29/2016

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

D2 MIDC , Ahmednagar, Maharashtra INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

PLOT NO.74B, JAWAHARLAL NEHRU , PHARMA CITY, PARAWADA , VISAKHAPATNAM, Andhra Pradesh INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

G.T. Road , Shingla Carpets Building , Tehsil, Panipat, HaryanaINDIA

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Page 26: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Suchem Laboratories Date Published : 04/30/2015

Suprima Cosmo Tech Date Published : 11/01/2016

Universal Esters Ltd. Date Published : 12/13/2016

63 Human and Animal Drugs Date Published: 06/29/2016

64 Human and Animal Drugs Date Published: 06/29/2016

65 Human and Animal Drugs Date Published: 06/29/2016

66 Human and Animal Drugs Date Published: 06/29/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 04/30/2015

56 Antibiotics (Human/Animal) Date Published: 04/30/2015

60 Human and Animal Drugs Date Published: 04/30/2015

61 Human and Animal Drugs Date Published: 04/30/2015

62 Human and Animal Drugs Date Published: 04/30/2015

63 Human and Animal Drugs Date Published: 04/30/2015

64 Human and Animal Drugs Date Published: 04/30/2015

65 Human and Animal Drugs Date Published: 04/30/2015

66 Human and Animal Drugs Date Published: 04/30/2015

53 D Fragrance Prep Date Published: 11/01/2016

53 L Skin Care Prep Date Published: 11/01/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 11/01/2016

56 Antibiotics (Human/Animal) Date Published: 11/01/2016

60 Human and Animal Drugs Date Published: 11/01/2016

61 Human and Animal Drugs Date Published: 11/01/2016

62 Human and Animal Drugs Date Published: 11/01/2016

63 Human and Animal Drugs Date Published: 11/01/2016

64 Human and Animal Drugs Date Published: 11/01/2016

65 Human and Animal Drugs Date Published: 11/01/2016

66 Human and Animal Drugs Date Published: 11/01/2016

53 Cosmetics Date Published: 12/13/2016

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Notes:All Drug and Drug Products;For industry code 53, only products found to be drug products are subject to DWPE under thislisting.

Jalaram Party Plot , #10/13 Phase I; Service Road , Daskroi, Gujarat INDIA

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

26/A, Osiya Mata Compound , Reti Bunder Road, Kalher Village , Bhiwandi, Thane, Maharashtra INDIA

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Desc:All Drug and Drug Products Notes:The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code 53. Any productsdetermine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

Notes:All Drug and Drug Products;The firm has a history of shipping apparent drug products (i.e. petroleum jelly) under Industry Code53. Any products determine to be drug products shipped under Industry Code 53 are subject to DWPE under this listing.

1088/B Manjusar Village , Lamdapura Road, Savli , Vadodara, Gujarat INDIA

Desc:All Drug and Drug Products

Page 27: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Salf Spa Laboratorio Farmacologico Date Published : 05/18/2015

INABA FOODS CO.,LTD. Date Published : 08/24/2011

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 12/13/2016

56 Antibiotics (Human/Animal) Date Published: 12/13/2016

60 Human and Animal Drugs Date Published: 12/13/2016

61 Human and Animal Drugs Date Published: 12/13/2016

62 Human and Animal Drugs Date Published: 12/13/2016

63 Human and Animal Drugs Date Published: 12/13/2016

64 Human and Animal Drugs Date Published: 12/13/2016

65 Human and Animal Drugs Date Published: 12/13/2016

66 Human and Animal Drugs Date Published: 12/13/2016

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 05/18/2015

60 Human and Animal Drugs Date Published: 05/18/2015

61 Human and Animal Drugs Date Published: 05/18/2015

62 Human and Animal Drugs Date Published: 05/18/2015

63 Human and Animal Drugs Date Published: 05/18/2015

64 Human and Animal Drugs Date Published: 05/18/2015

65 Human and Animal Drugs Date Published: 05/18/2015

66 Human and Animal Drugs Date Published: 05/18/2015

02 Whole Grain/Milled Grain Prod/Starch Date Published: 08/24/201103 Bakery Prod/Dough/Mix/Icing Date Published: 08/24/201104 Macaroni/Noodle Prod Date Published: 08/24/201105 Cereal Prep/Breakfast Food Date Published: 08/24/201107 Snack Food Item Date Published: 08/24/201109 Milk/Butter/Dried Milk Prod Date Published: 08/24/201112 Cheese/Cheese Prod Date Published: 08/24/201113 Ice Cream Prod Date Published: 08/24/201114 Filled Milk/Imit Milk Prod Date Published: 08/24/201115 Egg/Egg Prod Date Published: 08/24/201116 Fishery/Seafood Prod Date Published: 08/24/201117 Meat, Meat Products and Poultry Date Published: 08/24/201118 Vegetable Protein Prod Date Published: 08/24/201120 Fruit/Fruit Prod Date Published: 08/24/201121 Fruit/Fruit Prod Date Published: 08/24/201122 Fruit/Fruit Prod Date Published: 08/24/201123 Nuts/Edible Seed Date Published: 08/24/201124 Vegetables/Vegetable Products Date Published: 08/24/201125 Vegetables/Vegetable Products Date Published: 08/24/201126 Vegetable Oils Date Published: 08/24/201127 Dressing/Condiment Date Published: 08/24/201128 Spices, Flavors And Salts Date Published: 08/24/201129 Soft Drink/Water Date Published: 08/24/201130 Beverage Bases/Conc/Nectar Date Published: 08/24/201131 Coffee/Tea Date Published: 08/24/201132 Alcoholic Beverage Date Published: 08/24/201133 Candy W/O Choc/Special/Chew Gum Date Published: 08/24/201134 Choc/Cocoa Prod Date Published: 08/24/201135 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 08/24/2011

Desc:All Drug and Drug Products Notes:For Industry code 53[][][][]; only products found to be drug products are subject to DWPE under this listing.

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

Notes:All Drug and Drug Products;

ITALYVia Guglielmo Marconi 2 , Trescore Balneario, Bergamo ITALY

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

JAPAN1141,KITADA , YUICHO,IHARACOUNTY, JP22 JAPAN

Page 28: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Inaba Foods Corporation Date Published : 08/24/2011

35 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 08/24/201136 Food Sweeteners (Nutritive) Date Published: 08/24/201137 Mult Food Dinner/Grav/Sauce/Special Date Published: 08/24/201138 Soup Date Published: 08/24/201139 Prep Salad Prod Date Published: 08/24/201140 A Baked Goods (Baby) Date Published: 08/24/201140 B Cereal (Baby) Date Published: 08/24/201140 C Formula Prod (Baby) Date Published: 08/24/201140 D Veg (Baby) Date Published: 08/24/201140 E Fruit/Juice/Drink (Baby) Date Published: 08/24/201140 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 08/24/201140 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 08/24/201140 H High Meat Dinner/Cheese Food (Baby) Date Published: 08/24/201140 I FishSeafood Prod (Baby) Date Published: 08/24/201140 J Egg Prod (Baby) Date Published: 08/24/201140 K Pudding/Custard (Baby) Date Published: 08/24/201140 L Soups/Soup Mix (Baby) Date Published: 08/24/201140 M Infant Formula Raw Material Date Published: 08/24/201140 N Ready To Feed Formula Products Date Published: 08/24/201140 O Liquid Concentrate Formula Products Date Published: 08/24/201140 P Powder Formula Products Date Published: 08/24/201140 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 08/24/201140 R Infant Formula For Sample Testing (not for sale) Date Published: 08/24/201140 X Market Basket Sampling Date Published: 08/24/201140 Y Baby Food N.E.C. Date Published: 08/24/201141 Dietary Conv Food/Meal Replacements Date Published: 08/24/201152 B 06 Corn Husks (Food Related) Date Published: 08/24/201152 B 07 Snail Shells (Food Related) Date Published: 08/24/201152 B 08 Sausage Casings, Artificial (Food Related) Date Published: 08/24/201152 B 12 Bird's Nest Date Published: 08/24/201152 D Live Animals Date Published: 08/24/201152 E Infant Food Items Date Published: 08/24/2011

02 Whole Grain/Milled Grain Prod/Starch Date Published: 08/24/201103 Bakery Prod/Dough/Mix/Icing Date Published: 08/24/201104 Macaroni/Noodle Prod Date Published: 08/24/201105 Cereal Prep/Breakfast Food Date Published: 08/24/201107 Snack Food Item Date Published: 08/24/201109 Milk/Butter/Dried Milk Prod Date Published: 08/24/201112 Cheese/Cheese Prod Date Published: 08/24/201113 Ice Cream Prod Date Published: 08/24/201114 Filled Milk/Imit Milk Prod Date Published: 08/24/201115 Egg/Egg Prod Date Published: 08/24/201116 Fishery/Seafood Prod Date Published: 08/24/201117 Meat, Meat Products and Poultry Date Published: 08/24/201118 Vegetable Protein Prod Date Published: 08/24/201120 Fruit/Fruit Prod Date Published: 08/24/201121 Fruit/Fruit Prod Date Published: 08/24/201122 Fruit/Fruit Prod Date Published: 08/24/201123 Nuts/Edible Seed Date Published: 08/24/201124 Vegetables/Vegetable Products Date Published: 08/24/201125 Vegetables/Vegetable Products Date Published: 08/24/201126 Vegetable Oils Date Published: 08/24/201127 Dressing/Condiment Date Published: 08/24/201128 Spices, Flavors And Salts Date Published: 08/24/201129 Soft Drink/Water Date Published: 08/24/201130 Beverage Bases/Conc/Nectar Date Published: 08/24/201131 Coffee/Tea Date Published: 08/24/201132 Alcoholic Beverage Date Published: 08/24/201133 Candy W/O Choc/Special/Chew Gum Date Published: 08/24/201134 Choc/Cocoa Prod Date Published: 08/24/201135 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 08/24/201136 Food Sweeteners (Nutritive) Date Published: 08/24/201137 Mult Food Dinner/Grav/Sauce/Special Date Published: 08/24/201138 Soup Date Published: 08/24/201139 Prep Salad Prod Date Published: 08/24/201140 A Baked Goods (Baby) Date Published: 08/24/2011

40 B Cereal (Baby) Date Published: 08/24/2011

1141 KitadaCho, YuiCho , IharaGun, Shizuoka JAPAN

Page 29: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Inaba Shokuhin Kk Date Published : 08/24/2011

40 B Cereal (Baby) Date Published: 08/24/201140 C Formula Prod (Baby) Date Published: 08/24/201140 D Veg (Baby) Date Published: 08/24/201140 E Fruit/Juice/Drink (Baby) Date Published: 08/24/201140 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 08/24/201140 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 08/24/201140 H High Meat Dinner/Cheese Food (Baby) Date Published: 08/24/201140 I FishSeafood Prod (Baby) Date Published: 08/24/201140 J Egg Prod (Baby) Date Published: 08/24/201140 K Pudding/Custard (Baby) Date Published: 08/24/201140 L Soups/Soup Mix (Baby) Date Published: 08/24/201140 M Infant Formula Raw Material Date Published: 08/24/201140 N Ready To Feed Formula Products Date Published: 08/24/201140 O Liquid Concentrate Formula Products Date Published: 08/24/201140 P Powder Formula Products Date Published: 08/24/201140 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 08/24/201140 R Infant Formula For Sample Testing (not for sale) Date Published: 08/24/201140 X Market Basket Sampling Date Published: 08/24/201140 Y Baby Food N.E.C. Date Published: 08/24/201141 Dietary Conv Food/Meal Replacements Date Published: 08/24/201152 B 06 Corn Husks (Food Related) Date Published: 08/24/201152 B 07 Snail Shells (Food Related) Date Published: 08/24/201152 B 08 Sausage Casings, Artificial (Food Related) Date Published: 08/24/201152 B 12 Bird's Nest Date Published: 08/24/201152 D Live Animals Date Published: 08/24/201152 E Infant Food Items Date Published: 08/24/2011

02 Whole Grain/Milled Grain Prod/Starch Date Published: 08/24/201103 Bakery Prod/Dough/Mix/Icing Date Published: 08/24/201104 Macaroni/Noodle Prod Date Published: 08/24/201105 Cereal Prep/Breakfast Food Date Published: 08/24/201107 Snack Food Item Date Published: 08/24/201109 Milk/Butter/Dried Milk Prod Date Published: 08/24/201112 Cheese/Cheese Prod Date Published: 08/24/201113 Ice Cream Prod Date Published: 08/24/201114 Filled Milk/Imit Milk Prod Date Published: 08/24/201115 Egg/Egg Prod Date Published: 08/24/201116 Fishery/Seafood Prod Date Published: 08/24/201117 Meat, Meat Products and Poultry Date Published: 08/24/201118 Vegetable Protein Prod Date Published: 08/24/201120 Fruit/Fruit Prod Date Published: 08/24/201121 Fruit/Fruit Prod Date Published: 08/24/201122 Fruit/Fruit Prod Date Published: 08/24/201123 Nuts/Edible Seed Date Published: 08/24/201124 Vegetables/Vegetable Products Date Published: 08/24/201125 Vegetables/Vegetable Products Date Published: 08/24/201126 Vegetable Oils Date Published: 08/24/201127 Dressing/Condiment Date Published: 08/24/201128 Spices, Flavors And Salts Date Published: 08/24/201129 Soft Drink/Water Date Published: 08/24/201130 Beverage Bases/Conc/Nectar Date Published: 08/24/201131 Coffee/Tea Date Published: 08/24/201132 Alcoholic Beverage Date Published: 08/24/201133 Candy W/O Choc/Special/Chew Gum Date Published: 08/24/201134 Choc/Cocoa Prod Date Published: 08/24/201135 Gelatin/Rennet/Pudding Mix/Pie Filling Date Published: 08/24/201136 Food Sweeteners (Nutritive) Date Published: 08/24/201137 Mult Food Dinner/Grav/Sauce/Special Date Published: 08/24/201138 Soup Date Published: 08/24/201139 Prep Salad Prod Date Published: 08/24/201140 A Baked Goods (Baby) Date Published: 08/24/201140 B Cereal (Baby) Date Published: 08/24/201140 C Formula Prod (Baby) Date Published: 08/24/201140 D Veg (Baby) Date Published: 08/24/201140 E Fruit/Juice/Drink (Baby) Date Published: 08/24/201140 F Meat Prod/Comb Meat Dinner (Baby) Date Published: 08/24/201140 G Poultry Prod/Comb Poultry Dinner (Baby) Date Published: 08/24/2011

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 08/24/2011

1141, Kitada, Yuicho , IharaGun, JAPAN

Page 30: I m p o r t A l e r t 9 9 3 2 · FDA H om e 3 Im p or t P r ogr am 4 Im p or t Al e r t s Im p or t s Al e r t s b y N u m b e r Im p or t Al e r t. Agr isan S pe cialty C h e m ical

Nippon Fine Chemical Co., LTD Date Published : 08/08/2016

40 H High Meat Dinner/Cheese Food (Baby) Date Published: 08/24/201140 I FishSeafood Prod (Baby) Date Published: 08/24/201140 J Egg Prod (Baby) Date Published: 08/24/201140 K Pudding/Custard (Baby) Date Published: 08/24/201140 L Soups/Soup Mix (Baby) Date Published: 08/24/201140 M Infant Formula Raw Material Date Published: 08/24/201140 N Ready To Feed Formula Products Date Published: 08/24/201140 O Liquid Concentrate Formula Products Date Published: 08/24/201140 P Powder Formula Products Date Published: 08/24/201140 Q Pasta and Noodle Combination Dinners Without Meat Date Published: 08/24/201140 R Infant Formula For Sample Testing (not for sale) Date Published: 08/24/201140 X Market Basket Sampling Date Published: 08/24/201140 Y Baby Food N.E.C. Date Published: 08/24/201141 Dietary Conv Food/Meal Replacements Date Published: 08/24/201152 B 06 Corn Husks (Food Related) Date Published: 08/24/201152 B 07 Snail Shells (Food Related) Date Published: 08/24/201152 B 08 Sausage Casings, Artificial (Food Related) Date Published: 08/24/201152 B 12 Bird's Nest Date Published: 08/24/201152 D Live Animals Date Published: 08/24/201152 E Infant Food Items Date Published: 08/24/2011

55 Pharm Necess & Ctnr For Drug/Bio Date Published: 08/08/2016

56 Antibiotics (Human/Animal) Date Published: 08/08/2016

60 Human and Animal Drugs Date Published: 08/08/2016

61 Human and Animal Drugs Date Published: 08/08/2016

62 Human and Animal Drugs Date Published: 08/08/2016

63 Human and Animal Drugs Date Published: 08/08/2016

64 Human and Animal Drugs Date Published: 08/08/2016

65 Human and Animal Drugs Date Published: 08/08/2016

66 Human and Animal Drugs Date Published: 08/08/2016

5 Chome 11 , Umei , Takasago, Hyogo JAPAN

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

Notes:All Drug and Drug Products

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R A P P O R T - institut-ega.org

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