# Valneva Austria GmbH – FDA 483, May 22, 2026

Source: https://www.keypedia.com/records/483/valneva-austria-gmbh/3dbfbb6c-aaea-4c27-b44a-56e909df0bee

> FDA 483 for Valneva Austria GmbH on May 22, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valneva Austria GmbH
- Inspection Date: 2026-05-22
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/valneva-austria-gmbh/66194b1b-2f22-4c17-bf51-36477cf94c61

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8