FDA Inspection 1099421 — Fresenius Kabi AB

Fresenius Kabi AB — FEI 3002631703

The FDA completed an inspection of Fresenius Kabi AB on October 16, 2018 in Uppsala. 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
October 16, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Uppsala (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)