Transcript NWE-DO Update

New England District Update
MassMEDIC Conference
December 2, 2009
Waltham, MA
New Hires
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33 Consumer Safety Officers
4 Supervisory Consumer Safety
Officers
3 Compliance Officers
3 Consumer Safety Technicians
New Hires
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District Director
Director Investigations Branch
Regional & Local Quality System Manager
Regional & Local State
Contract/Emergency Coordinator
Currently
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Investigations
• 9 SCSO
• 102 CSOs/CSIs
Currently
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Compliance
• 10 CO’s
• 1 FOI Specialist
Inventory
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8897 establishments
• 2892 device firms
Accomplishments
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1216 Inspections
• 254 Device inspections
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21 Foreign inspections
Recalls FY 08
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118 Total
• 56 Device
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4 Class I
48 Class II
4 Class III
Compliance Actions
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16 Warning Letters
• 4 Device QSRs
1 Indictment of firm & executives for fraudulent
marketing scheme
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Wire fraud
Conspiracy
Misbranding
False statements to FDA
If guilty
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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
(domestic/foreign)
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
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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
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Streamline Warning Letter process
• OCC review limited to significant legal issues
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Collaboration with regulatory partners
• State, local, international officials can act quicker
Commissioner’s Enforcement Initiatives
August 6 2009
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Prioritize follow-up on enforcement actions
• Inspection to ensure corrective actions
• Root cause identified
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Take immediate action in response to public
health risks
• FDA will act quickly and aggressively on public health
concerns
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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