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1103305

Cipla Limited — FEI 3004081307

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 27, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salcette (India)

Facility

Other inspections at this facility

  • 1240813 (VAI Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178952 (OAI Fri Aug 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078911 (VAI Mon Jan 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069950 (VAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015874 (NAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
354721 CFR 211.46(b)Equipment for Environmental Control
357021 CFR 211.100(a)Approval and review of procedures
360821 CFR 211.160(b)(2)Sampling/testing of in-process materials