Home / Inspections / 1066792

1066792

Sagent Pharmaceuticals — FEI 3006167046

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 24, 2018
Fiscal Year
2018
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

  • 1231342 (NAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114257 (VAI Wed Dec 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940865 (NAI Wed Aug 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782558 (VAI Fri May 11 2012 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
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
673621 CFR 314.80(c)(1)(ii)Submission of report follow-up
890821 CFR 314.81(b)(2)(i)Summary