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1102370

Genus Lifesciences Inc. — FEI 3003851100

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2019
Fiscal Year
2019
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))
  • 1073444 (NAI Wed Nov 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059468 (VAI Fri Jul 20 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
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration