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1059468

Genus Lifesciences Inc. — FEI 3003851100

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 20, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Allentown, PA (United States)

Facility

Other inspections at this facility

  • 1245779 (NAI Wed Jul 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102370 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073444 (NAI Wed Nov 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027671 (VAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982555 (NAI Thu Aug 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
184221 CFR 211.84(d)(1)Component identity verification
184621 CFR 211.84(d)(3)Establish reliability of supplier's C of A
189121 CFR 211.165(f)Failing drug products not rejected
202721 CFR 211.192Investigations of discrepancies, failures
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration