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710247

Genus Lifesciences Inc. — FEI 3003851100

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 3, 2011
Fiscal Year
2011
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))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls