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922881

Unichem Laboratories Ltd. — FEI 3004082076

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ghaziabad (India)

Facility

Other inspections at this facility

  • 1230023 (NAI Tue Feb 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102985 (VAI Fri Aug 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087477 (NAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053321 (NAI Fri Apr 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008000 (VAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls