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782558

Sagent Pharmaceuticals — FEI 3006167046

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Schaumburg, IL (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

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  • 1114257 (VAI Wed Dec 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066792 (VAI Mon Sep 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940865 (NAI Wed Aug 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717757 (NAI Fri Mar 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
682921 CFR 314.80(c)(2)Failure to report non-alert ADEs