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