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1043676

SUN PHARMACEUTICAL INDUSTRIES INC — FEI 3013472760

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 9, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Princeton, NJ (United States)

Facility

Other inspections at this facility

  • 1230974 (NAI Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179668 (NAI Wed Aug 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083409 (NAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068971 (NAI Tue Sep 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005521 (VAI Mon Mar 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
163721 CFR 211.130(e)Packaging line inspection after use
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair
440221 CFR 211.192Written record of investigation incomplete