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632085

Armstrong Pharmaceuticals, Inc. — FEI 3007009553

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 13, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Canton, MA (United States)

Facility

Other inspections at this facility

  • 1245297 (VAI Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1147623 (NAI Wed Jul 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872285 (NAI Thu Apr 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805461 (NAI Fri Oct 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785248 (VAI Thu Jun 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
202721 CFR 211.192Investigations of discrepancies, failures
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
435421 CFR 211.165(d)Acceptance/Rejection Levels
440621 CFR 211.194(a)(2)Suitability of testing methods verified