FDA 483 - Bavarian Nordic Berna GmbH - September 22, 2017

PaxVax Berna, a vaccine/drug manufacturer in Thörishaus, Switzerland, was inspected by the FDA from September 15-22, 2017. The inspection revealed significant issues related to unvalidated lyophilization process changes and a failure to file appropriate supplements for these changes. Additionally, the firm had deficiencies in its procedures and practices for evaluating adverse events and technical complaints.