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1055697

Torrent Pharmaceuticals Limited — FEI 3007078804

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Gandhi Nagar (India)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1256784 (NAI Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1161232 (NAI Wed Dec 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1051188 (NAI Wed Feb 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1802421 CFR 314.80(c)(2)(ii)(B)Periodic safety report missing ICSR
1802521 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
673021 CFR 314.80(b)Failure to develop written procedures