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1177459

Sun Pharmaceutical Industries Limited — FEI 3002807979

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 12, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mohali (India)

Facility

Other inspections at this facility

  • 1117962 (VAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094000 (NAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068079 (NAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 994372 (VAI Wed Nov 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812385 (OAI Wed Dec 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
430621 CFR 211.80(a)Written Procedures Not Followed