FDA 483 - Catalent Belgium SA - July 12, 2024

An FDA inspection of Catalent Belgium, S.A. revealed significant deficiencies in aseptic processing, environmental monitoring, and facility maintenance. The firm failed to establish and follow adequate procedures to prevent microbial contamination, conduct representative aseptic process simulations, and properly control its manufacturing processes. These issues indicate a high risk to drug product quality and sterility, compounded by inadequate facility upkeep and procedural non-compliance.