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1084595

Sun Pharmaceutical Industries Limited — FEI 3004561553

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dadra (India)

Facility

Other inspections at this facility

  • 1012008 (VAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915847 (VAI Fri Jan 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834084 (NAI Fri May 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 738976 (NAI Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
178721 CFR 211.80(a)Procedures To Be in Writing
203121 CFR 211.194(a)Complete test data included in records
356621 CFR 211.84(c)(4)Composite sample top/middle/bottom
361021 CFR 211.160(b)(3)Drug product sample
363221 CFR 211.170(b)Annual visual exams of drug products