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1112459

Jubilant Generics Limited — FEI 3006895982

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 6, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bhagwanpur (India)

Facility

Other inspections at this facility

  • 1231774 (VAI Fri Feb 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175958 (OAI Mon Aug 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1137148 (OAI Fri Mar 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007262 (NAI Thu Mar 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 971357 (VAI Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls