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1090627

Aurobindo Pharma Ltd — FEI 3004021229

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2019
Fiscal Year
2019
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
176821 CFR 211.137(b)Storage conditions
203121 CFR 211.194(a)Complete test data included in records
362321 CFR 211.170(a)Active ingredient retained sample kept
430521 CFR 211.68(b)Backup data not assured as exact and complete
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
440221 CFR 211.192Written record of investigation incomplete