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1211415

Marksans Pharma Limited — FEI 3006230648

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Verna (India)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1236614 (VAI Wed Apr 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014460 (VAI Fri Apr 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944722 (NAI Thu Sep 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795367 (NAI Fri Aug 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 627747 (VAI Fri Nov 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
670521 CFR 310.305(c)Failure to submit ADE report
673021 CFR 314.80(b)Failure to develop written procedures