1. New England District Update MassMEDIC Conference December 1, 2010 Waltham, MA

3. New Hires 11 Consumer Safety Officers 11 Consumer Safety Officers 5 Supervisory Consumer Safety Officers 5 Supervisory Consumer Safety Officers

4. New Hires Dara Corrigan Associate Commissioner for Regulatory Affairs

5. New Hires District Director District Director District Quality Manager District Quality Manager

6. Currently Investigations Investigations 11 SCSO 113 CSOs/CSIs

7. Currently Compliance Compliance 10 CO’s 1 FOI Specialist

8. Inventory 8745 establishments 8745 establishments 3021 device firms3021 device firms

9. Accomplishments 1355 Inspections 1355 Inspections 264 Device inspections264 Device inspections 20 Foreign inspections 20 Foreign inspections

10. Recalls FY 10 126 Total 126 Total 67 Device67 Device 6 Class I 6 Class I 55 Class II 55 Class II 6 Class III 6 Class III

11. Compliance Actions 22 Warning Letters 22 Warning Letters 9 Device QSRs9 Device QSRs 2 Permanent Injunctions 2 Permanent Injunctions

12. Compliance Actions 133 lines of imported devices detained worth about $2 million133 lines of imported devices detained worth about $2 million 53 refusals of imported devices worth about $164,00053 refusals of imported devices worth about $164,000

13. Compliance Actions Import Alert 99-32 "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION“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 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

14. FY11 Device Workplan INSPECTIONAL TYPENWE-DO (domestic/foreign) ORA (domestic/foreign) QSR156/ 141963 / 353 PMA14 / 5168 / 52 BIMO21 / 2295/ 25 TOTAL191 / 212426/ 354

15. Commissioner’s Enforcement Initiatives August 6 2009 Implement a formal Warning Letter “close-out” process Implement a formal Warning Letter “close-out” process After FDA determines violations have been corrected notice will be posted on FDA websiteAfter FDA determines violations have been corrected notice will be posted on FDA website For WL issued after 9/1/09For WL issued after 9/1/09 Warning Letter “close-out” process 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

16. FDA Track CDRH CDRH Total number of 510(k) decisions made during the monthTotal number of 510(k) decisions made during the month ORA ORA Total number of foreign food, drug and device inspections and their classifications per monthTotal 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 IndicatedNumber of highest risk domestic inspections in the month resulting in a classification of Official Action Indicated