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New England District Update

New England District Update. MassMEDIC Conference December 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

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New England District Update

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

  2. New Hires • 11 Consumer Safety Officers • 5 Supervisory Consumer Safety Officers

  3. New Hires Dara Corrigan  Associate Commissioner for Regulatory Affairs

  4. New Hires • District Director • District Quality Manager

  5. Currently • Investigations • 11 SCSO • 113 CSOs/CSIs

  6. Currently • Compliance • 10 CO’s • 1 FOI Specialist

  7. Inventory • 8745 establishments • 3021 device firms

  8. Accomplishments • 1355 Inspections • 264 Device inspections • 20 Foreign inspections

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

  10. Compliance Actions • 22 Warning Letters • 9 Device QSRs • 2 Permanent Injunctions

  11. Compliance Actions • 133 lines of imported devices detained worth about $2 million • 53 refusals of imported devices worth about $164,000

  12. 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

  13. FY11 Device Workplan

  14. Commissioner’s Enforcement InitiativesAugust 6 2009 • Implement a formal Warning Letter “close-out” process • After FDA determinesviolations 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

  15. 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

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