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987775

New Jersey Laboratories — FEI 2219935

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 23, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Brunswick, NJ (United States)

Facility

Other inspections at this facility

  • 1180024 (VAI Thu Sep 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009479 (NAI Wed Apr 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887267 (NAI Wed Jul 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787570 (VAI Fri Jun 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 656254 (NAI Fri Apr 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
361321 CFR 211.160(b)(4)Establishment of calibration procedures