New England District Update

MassMEDIC ConferenceDecember 1, 2010

Waltham, MA

New Hires 11 Consumer Safety Officers 5 Supervisory Consumer Safety

Officers

New Hires

Dara Corrigan Associate Commissioner

for Regulatory Affairs

New Hires District Director District Quality Manager

Currently Investigations

• 11 SCSO• 113 CSOs/CSIs

Currently Compliance

• 10 CO’s• 1 FOI Specialist

Inventory 8745 establishments

• 3021 device firms

Accomplishments 1355 Inspections

• 264 Device inspections 20 Foreign inspections

Recalls FY 10 126 Total

• 67 Device 6 Class I 55 Class II 6 Class III

Compliance Actions 22 Warning Letters

• 9 Device QSRs 2 Permanent Injunctions

Compliance Actions

• 133 lines of imported devices detained worth about $2 million

• 53 refusals of imported devices worth about $164,000

Compliance Actions• Import Alert 99-32 "DETENTION

WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION“

it appears that articles were manufactured, processed, or packed under insanitary conditions for purposes of section 801(a)(1) of the act thus refuse admission

FY11 Device WorkplanINSPECTIONAL TYPE NWE-DO

(domestic/foreign)ORA

(domestic/foreign)

QSR 156/ 14 1963 / 353

PMA 14 / 5 168 / 52

BIMO 21 / 2 295/ 25

TOTAL 191 / 21 2426/ 354

Commissioner’s Enforcement InitiativesAugust 6 2009

Implement a formal Warning Letter “close-out” process• After FDA determines violations have been corrected

notice will be posted on FDA website• For WL issued after 9/1/09

Warning Letter “close-out” process• Since 09/01/09 a total 26 WL have been issued, 11 close

out letters sent, 3 of which were device related

FDA Track

CDRH • Total number of 510(k) decisions made during

the month ORA

• Total number of foreign food, drug and device inspections and their classifications per month

• Number of highest risk domestic inspections in the month resulting in a classification of Official Action Indicated