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1096293

Inventia Healthcare Limited — FEI 3008232264

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 5, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Thane (India)

Facility

Other inspections at this facility

  • 1262970 (VAI Wed Feb 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944555 (NAI Fri Aug 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833331 (NAI Fri May 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
126321 CFR 211.68(b)Computer control of master formula records
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
203421 CFR 211.194(d)Laboratory equipment calibration records
358521 CFR 211.110(a)Control procedures to monitor and validate performance