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1061698

Aurobindo Pharma Ltd — FEI 3004021229

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Medchal (India)

Additional Details

Postmarket Adverse Drug Experience (PADE)

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))
  • 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
673021 CFR 314.80(b)Failure to develop written procedures
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report