Bavarian Nordic Berna GmbHSeptember 22, 2017

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

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Record Details

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.

Company: Bavarian Nordic Berna GmbH
Inspection Date: September 22, 2017
Product Type: Biologics
Office: Division of Advertising & Promotion
People: Burnell M. Henry (Investigator)
Jacqueline M. Diaz Albertini (investigator)

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ID · 95741743-2c93-4e26-9016-df2994a77737