EW'\.OIEECSJ -TI.fiE l)j\TEIS8LED

SEE REVERSE Rupa Pradhan, Investigator - 2/26/2016 OF THIS PAGE John L Zaccone, Investigator ---....--.:-~ .. POIIM FDA 483 (19101) INSPECTIONAL OBSERVATIONS PAGE I Of 6 PAGES

DEPARTMENT OF HEALm AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT AllllRESS~PHOIE-

One Montvale Avenue Stoneham, MA 02180 (781)587-7500 Fax:(781 )587-7556

01\lE(!I) CF ...a::J1DN

2/10/2016-2/26/2016* FEl HUJoi9EI(

3001451521

NAME AND lT1U! ~ 1NilMIJUAL lO WHON REPCIIT ISStlEJJ

Brian Corbley , Facility Team Leader FIRM-

Whole Foods Market North Atlantic Kitchen CITY, STATE. ZIP OOCE, COUN"IR'f

Everett, MA 02149-5506

STIIIEET~

9 Commercial St, Suite 300

~ 1:0Sl-IN8PI:CTED

Manufacturer

This document lists observations made by lhe FDA represeotative(s) during lhe inspectioo of your fucility. They are inspectjonal observations, aod do oot n:pn:sent a final Agc:ucy ddenninatiou regarding yoW" complianoc.. If yoo haw: ao objection reganling an observalion, or bave implemented, or plan to implement, corrective action in response to an observation, you rnay discuss the objection or action with lhc FDA representative(s) during lhe inspection or submit this infonnation to FDA Bt the address above. If you have any questions, please contad FDA Bt lhe piJCme number aod address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1 Failure to manufacture , package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Specifically, on 2/10/16, 2/16/16 and 2118116 the following conditions and practices were observed in the Assembly Room (K.4), K8/K9 Room, Veg Prep Room, Pre-Pack Room and Bulk Room:

A. On 2/10/16, you were mixing RTE pesto pasta directly under an area in the Assembly Room (K4) where condensate from ceiling joints was dripping on the surface below.

B. On 2/16116, you were holding an uncovered rack ofRTE mushroom quesadilla in the same area of the Assembly Room (K.4) where condensate from ceiling joints was dripping on the surface below.

C. On 211 0/16, you were transporting uncovered R TE vegetables through a doorway above which significant condensate had formed and was dripping. The doorway led to the Prepared Veg Cooler from the Veg Prep Room.

D. On 2/10/16, you were cutting chives and beets on a work surface directly under a leaking condensate drainage pipe in the Veg Prep Room.

E. On 2116/16, you were holding uncovered RTE egg salad in large white barrels that were placed in an area below the condenser that dripped approximately once ,per second from the condenser fan bolts in the K80C9 Room.

DEI"ARTMENT OF HEAL 111 AND HUMAN SERVICES FOOD AND ORLIOI\DMINISTRATION

DISTRICT AllORBISANJI'IOE .,._

One Montvale Avenue Stoneham, t1A 02180 (781 )587 -7500 Fax: (761)587-7556

TO-REPCJITISSUED

Bri a n Corbley , Faci l ity Team Leader

Whole Foods Market North Atlantic Kitchen

Everett, MA 02149-5506

111\TE(S)CW"~

2/10/2016-2/26/2016* ~

3001451521

9 commercial St, Suite 300

'TWEEST­

Manufacturer

~~

SEE REVERSE Rupa Pradhan, Investigator OF THIS PAGE J ohn L Zaccone, Investigator x._,_

INSPECTIONAL OBSERVATIONS

- 2/26/2016

PAGE Z 01' 6PAUI!S

F. On 2/16/16, you were transporting uncovered RlE couscous through an area in K8/K9 where condensate was dripping from an area around the fan bolt at approximately once per second.

G. On 2/10/16, 2/16/16, 2/18/16, you were holding RTE vegetables, utensils such as cutting boards, mandolins, st:ainless colanders and yellow plastic totes in close proximity to hand washing station in the V eg Prep Room. The band washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while washing soiled hands. Water was splashing onto covered and uncovered

vegetables as well as utensils and food containers.

H. On 2/16/16, you measured the sfrcngth of peracetic acid from the faucet in the Veg Prep Room with an Peracetic Acid that indicated its strength over 160 ppm (maximum level on the test strip). This concenttation exceeds the maximum level recommended by Iilii (b) (4) product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.

I. On 2/16116, your employee was perfmming multiple tasks in the Pre-Pack Room such as filling and weighing RTE egg salad onto retail packs, directly touching product and deeming wo:rt surfaces without hand washing or changing gloves in between tas\::s.

I. On 2/16/16, your employee performing multiple tasks in the Bulk-Pack Room when packing RTE quinoa cakes and assembling bulk cartons without hand washing or changing gloves in between tasks.

K. On 2/16/16, your employee in the Pre-Pack Room was quaternary ammonium based sanitizer 1o clean the work surface while another employee in close proximity was packing RTE mesculin salad. lbis resulted in sanitizer being sprayed onto an open colander of salad

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SEE REVERSE Rupa Pradhan, Investigator - 2/26/2016 OF THIS PAGE John 1 Zaccone, Invest i gator x--.... --~ .... -. ...... FORM mA43(09,_) I'IIJl\IIOtr.l EDITlO!I OBliOUm! INSPEcriONAL OBSERVATIONS PA(i£ 3 Of 6 PA(iES

DEPARTMENT OF HEAL ni AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADOREBS/Hl.PHOIE,._ 110.'\'E(II)OF IIIGI'IImOOt

One Mont vale Avenue 2/10/2016-2 /2 6/201 6* Stoneham, MA 02180 FEl-lER

(781} 587-7500 Fax :( 781 )587-7556 30014 51521

!lAME AND TITlE OF 1NDM0UAL TO-REPQifT ISSUED

Brian Corblcy 1 Faci l ity Team Leader -- Olll<li:l:f~

Whole Foods Market North Atlantic 9 Commercial St , Suite 300 Kitchen CITY, STATE. ZF au. COIJHll'n' TWI>an"--~

Everett, MA 02149-5506 Manufacturer

leafy greens.

L. On 2/16/16, your employee's unprotected upper sleeves were frequently touching RTE leafy saJBd greens as they were assembling leafy salad greens into retail packs in the Pre-Pack Room.

OBSERVATION Z Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.

Specifically, the presence of non-pathogenic bacteria Listeria welshimeri was found on the enviroD.I:nental swab collected from the internal rotating drum portion of the WIQW machine (vegetable chopping) located in the Veg Prep Room on 2/10/16 at 12:07 PM. The presence of non-pathogenic bacteria Listeria welshimeri is indicative of failure to maintain food contact surfaces of equipment in an acceptable condition through appropriate cleaning and sanitizing. See Observation # 4-A, 4-B for cleaning and sanitizing of el}uipmerrt.

OBSERVATION 3 Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned.

Specifically,

J.l A .M. On 2/16/16, you had filled the dip tank for soaking sheet pans (used for raw meats and RTE in

process and finished products) with a sanitizing agent tliiiiJ quaternary ammonimn based

sanitizer). You measured the sanitizer strength using a color based- Test strip which indicated the sanitizer strength of 1 OOppm. This strength is not adequate for sanitizing food contact surfaces as per the recommended limit identified as 200-400ppm by the manufacturer.

DISTRicT AIIMESSNID~-

DEPARTMENT OF HEALTH AND HUMAN SERVICES fOOD AND DRUG ADMINISTRATION

MTE(!UOFIIISPS:11DII

Qne Montvale Avenue 2 / 1 0/201 6-2/26/2 0 16* Stoneham, MA 02180 (7 81 )~87 -7500 Fax: (7 81) 5 8 7-755 6

NAME AH0 mu: OF IIOVIIlUAI. TO WHOM~ ISS>JID

Brian Corbley , Facility Team Leader FIRIIIIWE

Whole Foods Marke t North Atlantic Ki tchen

FeiNIJN!IER

30014 51521

.,RI:ET_ 9 Commercial St, Suite 3 00

Everet t, MA 02149-5506 Manufacturer

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SEE REVERSE Rupa Pra dhan, I nvestigator OF THIS PAGE John L Zaccone , Investigator

FORM rDA 4U (119/UI) INSPECTIONAL OBSERVATIOII.'S

- 2/26/2016

PAGI! 4 OF 6 PAG!lS

tl .B ,...N. On 2116/16, you measured the sanitizer streJJgtb on the spray nozzle located in the dish washing

room that is used for filling dip tank and for sanitizing larger portable equipment and parts such

as rotating blades of[(Ugmachine and Ribbon Blender parts. The color bas~ Test strip indicated sanitizer strength of I OOppm. This strength is not adequate for sanitizing food

contact swfaces as per the rcconunended limit identified as 200-400ppm by the manufacturer.

{!_ 2/16/16. you did not clean and sanitize the semi-permanent divider curtain in the K8/K9 Room after using high pressure spray hose to clean and sanitize the ribbon blender and the walls and floors smrounding the ribbon blender.

/.On

J)/. On 2110/16, you were storing various utensils and equipment parts inside containers and on

rolling carts that had pooling water.

OBSERVATION4 Proper precautions to protect food and food-contact surfaces from contamination with chemicals , filth and extraneous material cannot be taken bee awe of deficiencies in plant design.

Specifically. on 2/10, 2/11, 2116 and 2118/16 the following conditions were observed:

A. You are using portable divider curtains and semi-permanent divider curtains to segregate areas between dishwashing room entrance and exit doors and tbe Assembly Room (K.4) to keep soiled

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUO ADMINISTRATION

""''KICT-NCPHOE-Qne Montvale Avenue Stoneham, MA 02180 (781)587-7500 Fax:(781)587-7556

NAME AND '!TilE OFIN:lMilUI\I. TO~~· .....,.,..

Brian Corbley , Facility Team Leader FIRM,_

Whole Foods Market North Atlantic Kitchen ClYY, STATE. ZP ocoe, OOLNTR!'

Everett, MA 02149-5506

sma:r-

I».TE(II)

2/10/2016-2/26/2016* FEINUMI!ER

30014 51521

9 Commercial St, Suite 300

Manufacturer

dishes separate from the RTE products assembled and in the Assembly Room (K4). However, soiled equipment from various preparation processes including holding of raw chicken and turkey were touching both sides of the portable divider curtains. See Observation # 4-C for cleaning and sanitation of these divider curtains.

B. You are using portable and semi-permanent divider curtains to segregate an area in the K8/K9 room when clean-in-place equipment such as ribbon blenders are cleaned and sanitized adjacent to an area where and when R TE foods are prepared. On 2/1 0/16 and 2/16/16, your use of high pressure hoses to clean the ribbon blender and the curtains were causing water and aerosolized spray from the cleaning activity to go beyond the portable divider curtains and semi-permanent divider curtains into areas where RTE food such as couscous and salad dressings were being prepared. Therefore, these portable and semi-permanent divider curtains do not provide adequate protection ofRTE food when high pressure hoses are used to clean and sanitize clean-in-place equipment and the portable and semi-pennanent divider curtains. Furthennore, these portable divider curtains do not have a designated clean and unclean side or a designated area of use. See Observation # 4-C for cleaning and sanitation of these divider curtains.

C. On 2/10/16 and 2/16/16, soiled/unclean equipment bad accumulated beyond the entrance of the dish washing room. Soiled/unclean equipment. utensils and food containers were being held beyond the portable divider curtains separating the dish washing room and the Assembly Area (K4). This resulted in soiled/unclean equipment to be held for indefinite period of time in close proximity toRTE preparation activities such as making of enchiladas, mixing of pesto pasta and quesadillas. The existing entry and exit doors of the dish washing room that opens into the busy Assembly Room (K4) where RTE products are prepared and the limited capacity of the dish washing room may contribute to this condition.

OBSERVATION 5 Hand-washing facilities lack running water of a suitable temperature.

liW\.D\'f!E(I)-~ 01\TE ISl!UED

SEE REVERSE Rupa Pradhan, Investigator OF THIS PAGE John L Zaccone, Investigator ---

2/26/2016

X ~q~a--

... )lr\_ ........

INSPECTIONAL OBSERVATIONS PAGES OF 6 PAGES

DEPARTMENT OF HEALTII AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT AIJDRI:SSAMlPHOIE ,._ DATEIS) Of' INSf>ECI1CH

One Montvale Avenue 2/10/2016-2/26/2016* Stoneham, MA 02180 I'EINW!IER

(781)587-7500 Fax:( 781) 587- 7556 3001451521

NAN!; A liD 1TI\.E OF IIIDMOWII.. TO ISSUED

Brian Corbley , Facility Team Leader ,__ l<llll:r ADilR£1!8

Whole Foods Market North Atlantic 9 Commercial St, Suite 300 Kitchen CITY. STATE. Z1P c:oDE. COUNI1n' nPei:BJ: INIII'£CJED

Everett, MA 02149-5506 Manufacturer

Specifically, on 2116/16 the hand washing station located at the entrance of the K8/K.9 room did not have warm/hot water. Your employees returning from break and other non food related tasks continued to use this tagged 110ut of service, no hot water, 2/16/16" hand washing sink before returning to preparing and handling RTE products. -OBSERVATION 6 Failure to properly identify toxic sanitizing agents in a manner that protects against contamination of food.

Specifically, on 2116/16 an un.madced drum of chemical that was connected to the vegetable preparation sink was observed in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.

*DATES OF INSPECTION 2/I0/2016(Wed),2/l l/2016(Thu),2/16/2016(Tue),2/18f2016(Thu),2/2612016(Fri)

2/ZIIf2VI6

X John l Zilmlne Jallnll.oaora -u-v ~Dr: Jalla-Jr-S

SEE REVERSE OFTHJS PAGE

EIIII'LCM:I!(19 -l\.R:

Rupa Pradhan, Investigator John L Zaccone, Investigator

-X RllpoMdhan ---__ 61r: ___ ..

DATE lllllil.ED

2/26/2016

PORM FDA 4al (09101) JIRBVIOUS l!tlll'IOif CliiSO..ETII INSPECflONAL OBSERVATIONS PAGE 6 OF 6 PAGES

' "

The observations of objectionable conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or

2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

Section 704(b) of the Federal Food, Drug, and Cosmetic Ad. (21 USC 374(b)} provides:

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving lhe premiseS, the officer or employee making the inspection shall give to the owner, operator, or agent In charge a report in writing setting forth any conditions or practices observed by him which, In his judgment indicate that any food, drug, device, or rosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed subs1ance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."