Transcript NWE-DO Update

New England District Update
MassMEDIC Conference
December 1, 2010
Waltham, MA
New Hires

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11 Consumer Safety Officers
5 Supervisory Consumer Safety
Officers
New Hires
Dara Corrigan
Associate Commissioner
for Regulatory Affairs
New Hires


District Director
District Quality Manager
Currently

Investigations
• 11 SCSO
• 113 CSOs/CSIs
Currently

Compliance
• 10 CO’s
• 1 FOI Specialist
Inventory

8745 establishments
• 3021 device firms
Accomplishments
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1355 Inspections
• 264 Device inspections
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20 Foreign inspections
Recalls FY 10

126 Total
• 67 Device

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6 Class I
55 Class II
6 Class III
Compliance Actions
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22 Warning Letters
• 9 Device QSRs
2 Permanent Injunctions
Compliance Actions
• 133 lines of imported devices
detained worth about $2 million
• 53 refusals of imported devices
worth about $164,000
Compliance Actions
• Import Alert 99-32 "DETENTION
WITHOUT PHYSICAL EXAMINATION OF
PRODUCTS FROM FIRMS REFUSING FDA
FOREIGN ESTABLISHMENT
INSPECTION“

it appears that articles were manufactured,
processed, or packed under insanitary
conditions for purposes of section 801(a)(1)
of the act thus refuse admission
FY11 Device Workplan
INSPECTIONAL TYPE
NWE-DO
(domestic/foreign)
ORA
(domestic/foreign)
QSR
156/ 14
1963 / 353
PMA
14 / 5
168 / 52
BIMO
21 / 2
295/ 25
TOTAL
191 / 21
2426/ 354
Commissioner’s Enforcement Initiatives
August 6 2009

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

Warning Letter “close-out” process
• Since 09/01/09 a total 26 WL have been issued, 11
close out letters sent, 3 of which were device related
FDA Track
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CDRH
• Total number of 510(k) decisions made during
the month
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ORA
• Total number of foreign food, drug and device
inspections and their classifications per month
• Number of highest risk domestic inspections in
the month resulting in a classification of
Official Action Indicated