FDA 483 - Bavarian Nordic A/S - November 07, 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, insufficient procedures for preventing microbiological contamination, and issues with aseptic process simulations and data integrity. These issues indicate a lack of robust quality control and manufacturing practices for their Jynneos/Imvamune/Imvanex vaccine products.