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962308

Fresenius Kabi USA, LLC — FEI 3001833549

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 4, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grand Island, NY (United States)

Facility

Other inspections at this facility

  • 1220482 (VAI Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216357 (NAI Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099323 (VAI Mon Aug 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014707 (VAI Thu Mar 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002820 (VAI Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls