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1210950

Aurobindo Pharma Ltd — FEI 3004021229

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Medchal (India)

Facility

Other inspections at this facility

  • 1155879 (VAI Fri Jul 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090627 (VAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061698 (VAI Fri Aug 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010385 (VAI Tue Apr 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 960797 (NAI Fri Jan 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
180921 CFR 211.160(a)Following/documenting laboratory controls
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation