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FDA Inspection 1099323 — Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC — FEI 3001833549

The FDA completed an inspection of Fresenius Kabi USA, LLC on August 12, 2019 in Grand Island, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 12, 2019
Fiscal Year
2019
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))
  • 1014707 (NAI 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))
  • 962308 (VAI Thu Feb 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources