FDA Inspection 1074710 — Bavarian Nordic Berna GmbH

Bavarian Nordic Berna GmbH — FEI 3011237656

The FDA completed an inspection of Bavarian Nordic Berna GmbH on December 14, 2018 in Thorishaus. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Thorishaus (Switzerland)