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

Bavarian Nordic A/S, a licensed biological drug manufacturer in Kvistgard, Denmark, was cited for significant quality control failures during an FDA inspection. Observations included inadequate investigations into Water for Injection (WFI) and particulate contamination affecting Jynneos vaccine and other drug products, and deficiencies in their Aseptic Process Simulation program. Additionally, the firm failed to visually inspect reserve samples and did not report a biological product deviation within the required timeframe.