FDA 483 - Bavarian Nordic Berna GmbH - December 06, 2018

An FDA inspection of PaxVax Berna GmbH, a vaccine manufacturer in Thörishaus, Switzerland, revealed significant deficiencies across its quality systems. The firm failed to adequately test drug products for objectionable microorganisms, conduct thorough investigations into discrepancies and defects, and report biological product deviations within the required timeframe. Additionally, issues were noted with adverse event reporting procedures, environmental monitoring, labeling accuracy, and adherence to manufacturing protocols, indicating a need for comprehensive corrective actions.