FDA 483 - Bavarian Nordic A/S - December 09, 2025

Bavarian Nordic A/S received a Form FDA 483 citing significant deficiencies in quality control and manufacturing processes at its Kvistgard facility. Observations included inadequate investigations into WFI and particulate contamination, failures in the aseptic process simulation program, and a lack of annual visual inspection for reserve samples. Additionally, the firm failed to report a biological product deviation within the mandated timeframe.