FDA 483 - Valneva Scotland Ltd. - February 17, 2026

An FDA inspection of Valneva Scotland Ltd., a manufacturer of IXIARO drug substance and bulk drug product, identified significant deficiencies across multiple areas. Findings included poorly maintained facilities with rust and peeling materials, an inadequate environmental monitoring program, and deficient aseptic processing practices. The firm also exhibited poor documentation practices, an unscientific aseptic process simulation program, and an ineffective cleaning program, indicating a broad lack of control over manufacturing operations.