FDA Inspection 1216357 — Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC — FEI 3001833549

The FDA completed an inspection of Fresenius Kabi USA, LLC on August 30, 2023 in Grand Island, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 30, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Grand Island, NY (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures