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1169254

Sun Pharmaceutical Industries Ltd. — FEI 3002809586

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 9, 2022
Fiscal Year
2022
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))
  • 1112832 (OAI Fri Dec 13 2019 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
111121 CFR 211.25(a)Training , Education , Experience overall
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls