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1048097

Alembic Pharmaceuticals Limited — FEI 3004956904

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Panchmahal (India)

Facility

Other inspections at this facility

  • 1242965 (NAI Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123365 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069852 (NAI Fri Oct 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967744 (VAI Fri Mar 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921484 (NAI Fri Feb 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures