FDA Inspection 1301512 — Fresenius Kabi Austria Gmbh

Fresenius Kabi Austria Gmbh — FEI 3002807014

The FDA completed an inspection of Fresenius Kabi Austria Gmbh on May 23, 2025 in Linz. 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
May 23, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Linz (Austria)

Additional Details

Mutual Recognition Agreement (MRA)