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1112832

Sun Pharmaceutical Industries Ltd. — FEI 3002809586

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 13, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halol (India)

Facility

Other inspections at this facility

  • 1272871 (OAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169254 (OAI Mon May 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095656 (VAI Tue Jun 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076538 (NAI Thu Dec 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064495 (NAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls