FDA 483 - Bavarian Nordic A/S - November 07, 2023

An FDA Form 483 was issued to a pharmaceutical company (name redacted) following an inspection conducted from October 30 to November 7, 2023. The inspection revealed several significant observations related to quality control, manufacturing processes, and facility maintenance, indicating deviations from current Good Manufacturing Practices.

A primary concern was the firm's failure to thoroughly investigate unexplained discrepancies. Specifically, metal particles were found in a distribution system used for Jynneos/Imvamune/Imvanex vaccine drug substance manufacturing, potentially impacting 37 drug product batches. Furthermore, complaints regarding particles in Jynneos vaccine were not adequately investigated.

Additional observations included insufficient equipment maintenance, such as dark brown discoloration on vial filling equipment without established replacement schedules, posing a contamination risk. Procedures for preventing microbiological contamination in sterile drug products were found inadequate, with unclear surface sampling techniques. The firm also failed to visually inspect approximately 1104 reserve samples of Jynneos Final Drug Products for signs of deterioration. Aseptic process simulations did not accurately reflect routine manufacturing hold times, and a lack of established maintenance procedures for specific Jynneos drug substance manufacturing equipment was noted. Finally, computer system audit trails revealed uninvestigated "assay testing aborted" events, indicating a lapse in data accuracy verification. The firm is required to address these observations by implementing comprehensive corrective and preventative actions.