FDA 483 - Valneva Scotland Ltd. - March 05, 2024

An FDA inspection of Valneva Scotland Ltd. in Livingston, United Kingdom, revealed significant deficiencies in their biologics/vaccine manufacturing operations. Observations included inadequate environmental monitoring in aseptic processing areas, a quality control unit failing to timely close deviations and manage change requests, and deficient procedures for handling product complaints. Additionally, issues were noted with the drug substance sampling strategy for mycobacteria testing and batch record documentation.