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1272871

Sun Pharmaceutical Industries Ltd. — FEI 3002809586

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Halol (India)

Facility

Other inspections at this facility

  • 1169254 (OAI Mon May 09 2022 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
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls