483
Valneva Austria GmbHValneva Austria GmbH – FDA 483, May 22, 2026
Record Details
Valneva Austria GmbH, a licensed biological drug manufacturer in Vienna, was cited for two significant issues during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and extend shelf-life impact assessments to U.S.-distributed batches of IXIARO, despite identifying potency issues in non-U.S. batches. Additionally, the firm failed to submit a required Biological Product Deviation Report within 45 days for a batch that failed potency specifications.
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