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1033982

Cipla Limited — FEI 3002806710

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Raigad (India)

Facility

Other inspections at this facility

  • 1235546 (VAI Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112254 (VAI Wed Nov 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953633 (VAI Fri Oct 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921003 (NAI Fri Feb 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 796510 (NAI Wed Jun 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
135821 CFR 211.100(b)SOPs not followed / documented
180921 CFR 211.160(a)Following/documenting laboratory controls
191221 CFR 211.166(a)Written program not followed
202521 CFR 211.188(b)(13)Results of drug product inspections and examinations
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure