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783661

Fresenius Kabi USA, LLC — FEI 3002733956

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 4, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Lake Zurich, IL (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1231341 (NAI Tue Aug 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113433 (NAI Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019250 (NAI Fri Apr 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897983 (NAI Mon Oct 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 640523 (NAI Thu Jan 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
670621 CFR 310.305(c)(1)(i)Late submission
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683221 CFR 314.80(c)(2)Late submission of annual safety reports