483
Bavarian Nordic Berna GmbHBavarian Nordic Berna GmbH – FDA 483, Sep 22, 2017
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.
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ID · 95741743-2c93-4e26-9016-df2994a77737
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