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1169446

Aurobindo Pharma Limited — FEI 3007373532

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Jedcherla Mandal, Mahabubnagar (India)

Facility

Other inspections at this facility

  • 1105823 (OAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022788 (NAI Sat Jun 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927596 (NAI Fri Mar 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787128 (NAI Tue Jun 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694644 (VAI Fri Jul 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
191221 CFR 211.166(a)Written program not followed
200921 CFR 211.188Prepared for each batch, include complete information
202821 CFR 211.192Extent of discrepancy, failure investigations