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1066469

Pfizer Healthcare India Private Limited — FEI 3008316085

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Visakhapatnam (India)

Facility

Other inspections at this facility

  • 1181610 (VAI Tue Oct 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106244 (OAI Fri Sep 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006274 (VAI Fri Mar 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941107 (VAI Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917613 (VAI Wed Feb 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications