FDA 483 - Sterigenics Belgium (Fleurus) S.A. - November 07, 2024
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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.
ID · 2f46a5cb-bca3-41da-a40c-a7736870ee6a