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FDA New England District Update: MassMEDIC Conference

Stay informed on the recent FDA activities in the New England District, including new hires, accomplishments, recalls, compliance actions, and enforcement initiatives. Learn about the regulatory updates and initiatives discussed at the MassMEDIC Conference.

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FDA New England District Update: MassMEDIC Conference

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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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