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988705

Fresenius Kabi USA, LLC — FEI 3008887707

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 24, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilson, NC (United States)

Facility

Other inspections at this facility

  • 1229851 (VAI Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208507 (VAI Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079248 (VAI Tue Feb 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026620 (NAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873402 (NAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
163021 CFR 211.130(b)Unlabeled filled containers controls
180921 CFR 211.160(a)Following/documenting laboratory controls
202421 CFR 211.188(b)(12)Documentation of Batch Investigations