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

An FDA inspection of Valneva Scotland Ltd. in Livingston, United Kingdom, a manufacturer of IXIARO drug substance and bulk drug product, revealed significant deficiencies across its manufacturing operations. Issues included poorly maintained facilities with rust, inadequate environmental monitoring and aseptic processing controls, poor documentation practices, and an ineffective cleaning program. The firm also failed to adequately qualify systems, address recurring particle contamination, monitor microbiological contamination, investigate product complaints thoroughly, and used unqualified reference standards, indicating systemic GMP non-compliance.