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1177670

Zydus Lifesciences Limited — FEI 3002984011

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 5, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Taluka Sanand, Ahmedabad (India)

Facility

Other inspections at this facility

  • 1088772 (OAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090231 (NAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047493 (NAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006533 (NAI Thu Feb 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895756 (OAI Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
178721 CFR 211.80(a)Procedures To Be in Writing
202721 CFR 211.192Investigations of discrepancies, failures