FDA Inspection 1140314 — Fresenius Kabi (Brunna Facility) AB

Fresenius Kabi (Brunna Facility) AB — FEI 3002996654

The FDA completed an inspection of Fresenius Kabi (Brunna Facility) AB on May 23, 2019 in Kungsangen. 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, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kungsangen (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)