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New England District Update

New England District Update. MassMEDIC Conference December 2, 2009 Waltham, MA. New Hires. 33 Consumer Safety Officers 4 Supervisory Consumer Safety Officers 3 Compliance Officers 3 Consumer Safety Technicians. New Hires. District Director Director Investigations Branch

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New England District Update

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  1. New England District Update MassMEDIC Conference December 2, 2009 Waltham, MA

  2. New Hires • 33 Consumer Safety Officers • 4 Supervisory Consumer Safety Officers • 3 Compliance Officers • 3 Consumer Safety Technicians

  3. New Hires • District Director • Director Investigations Branch • Regional & Local Quality System Manager • Regional & Local State Contract/Emergency Coordinator

  4. Currently • Investigations • 9 SCSO • 102 CSOs/CSIs

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

  6. Inventory • 8897 establishments • 2892 device firms

  7. Accomplishments • 1216 Inspections • 254 Device inspections • 21 Foreign inspections

  8. Recalls FY 08 • 118 Total • 56 Device • 4 Class I • 48 Class II • 4 Class III

  9. Compliance Actions • 16 Warning Letters • 4 Device QSRs • 1 Indictment of firm & executives for fraudulent marketing scheme • Wire fraud • Conspiracy • Misbranding • False statements to FDA • If guilty • Firm > $500,000 fine or 2x’s gross gain • Executives 20 yrs prison + fine > $250,000 or 2x’s gross gain

  10. Compliance Actions • 63 lines of imported devices detained

  11. FY10 Device Workplan

  12. Commissioner’s Enforcement InitiativesAugust 6 2009 • Post inspection deadlines (for EI’s o/a 9/15/09) • FR Vol. 74, No. 153, 8/11/09, 40211 – 40212 • 15 days to provide 483 response • Streamline Warning Letter process • OCC review limited to significant legal issues • Collaboration with regulatory partners • State, local, international officials can act quicker

  13. Commissioner’s Enforcement InitiativesAugust 6 2009 • Prioritize follow-up on enforcement actions • Inspection to ensure corrective actions • Root cause identified • Take immediate action in response to public health risks • FDA will act quickly and aggressively on public health concerns • 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

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