FDA 483 - Surgical Instruments Belgium SA (SIBEL S.A.) - March 19, 2026

Surgical Instruments Belgium SA (SIBEL S.A.) in Gembloux, Belgium, a medical device contract manufacturer, was cited for three observations during an FDA inspection. The inspection revealed significant issues with the validation of cleaning processes for surgical instruments, inadequate corrective actions for product nonconformities such as cracks in vascular clamps, and insufficient maintenance of risk management records. These findings indicate a lack of robust quality system controls for manufacturing and product safety.