Bavarian Nordic A/S – FDA 483, Nov 7, 2023

Bavarian Nordic A/S, a vaccine manufacturer in Kvistgard, Denmark, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures to thoroughly investigate discrepancies and complaints, inadequate equipment maintenance, and deficiencies in aseptic processing simulations and environmental monitoring procedures. The firm also lacked proper visual inspection of reserve samples and failed to ensure data accuracy in computer systems.