FDA 483 - Valneva Scotland Ltd. - September 09, 2022

An FDA inspection of Valneva Scotland Limited, a vaccine sterile bulk manufacturer in Livingston, Scotland, revealed significant deficiencies across multiple areas. The firm failed to maintain adequate quality control, including untimely deviation closures and insufficient investigations into particle contamination in JEV vaccine batches. Additionally, issues were noted in aseptic processing, laboratory controls, and employee training, indicating a broad lack of adherence to established procedures and good manufacturing practices.