New England District Update

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Presentation transcript:

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 Regional & Local Quality System Manager Regional & Local State Contract/Emergency Coordinator

Currently Investigations 9 SCSO 102 CSOs/CSIs

Currently Compliance 10 CO’s 1 FOI Specialist

Inventory 8897 establishments 2892 device firms

Accomplishments 1216 Inspections 254 Device inspections 21 Foreign inspections

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

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

Compliance Actions 63 lines of imported devices detained

FY10 Device Workplan INSPECTIONAL TYPE NWE-DO (domestic/foreign) ORA QSR 171 / 22 1859 / 286 PMA 14 / 5 169 / 53 BIMO 21 / 2 320 / 15 TOTAL 204 / 29 2225 / 354

Commissioner’s Enforcement Initiatives August 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

Commissioner’s Enforcement Initiatives August 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 determines violations have been corrected notice will be posted on FDA website For WL issued after 9/1/09