FDA 483 - Catalent Belgium SA - October 26, 2021

Catalent Belgium S.A. in Brussels was inspected and cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed failures in thoroughly investigating discrepancies like HEPA filter failures and environmental monitoring excursions, as well as inadequate process and cleaning validations for sterile products. Additionally, issues with equipment maintenance, facility design, and adherence to standard operating procedures were noted, indicating a broad lack of control over critical manufacturing processes.