FDA 483 - Sterigenics Belgium (Fleurus) S.A. - November 07, 2024

An FDA inspection of Sterigenics Belgium (Fleurus) S.A., a contract sterilizer in Fleurus, Belgium, from November 4-7, 2024, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow CAPA procedures, including addressing root causes, ensuring proper follow-up, and documenting corrective actions for identified issues. This indicates a moderate level of non-compliance with quality system requirements.