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1010385

Aurobindo Pharma Ltd — FEI 3004021229

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 18, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Medchal (India)

Facility

Other inspections at this facility

  • 1210950 (VAI Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 960797 (NAI Fri Jan 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
189021 CFR 211.165(e)Test methods
203121 CFR 211.194(a)Complete test data included in records
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls