FDA 483 - Excelvision - November 19, 2024

An FDA inspection of Exceivision in Annonay, Ardeche, France, revealed significant deficiencies in their drug manufacturing operations. The firm's complaint investigations for product contamination were inadequate, and their aseptic processing procedures, including smoke studies and media fills, lacked proper validation. Additionally, issues were noted with cleaning and disinfection systems, equipment maintenance in aseptic areas, and the absence of second-person review for laboratory environmental monitoring records.