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New England District Update
MassMEDIC Conference December 2, 2009 Waltham, MA
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New Hires 33 Consumer Safety Officers
4 Supervisory Consumer Safety Officers 3 Compliance Officers 3 Consumer Safety Technicians
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New Hires District Director Director Investigations Branch
Regional & Local Quality System Manager Regional & Local State Contract/Emergency Coordinator
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Currently Investigations 9 SCSO 102 CSOs/CSIs
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Currently Compliance 10 CO’s 1 FOI Specialist
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Inventory 8897 establishments 2892 device firms
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Accomplishments 1216 Inspections 254 Device inspections
21 Foreign inspections
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Recalls FY 08 118 Total 56 Device 4 Class I 48 Class II 4 Class III
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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
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Compliance Actions 63 lines of imported devices detained
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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
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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, – 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
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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
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