GRI

Sofibel company

Enforcement Healthcare & Pharma Sanctions & Fines
Date: 23rd Oct, 2024 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

The inspection of Sofibel's facility in Levallois-Perret, France, from June 12-14, 2024, identified significant non-conformities and deficiencies. Notified to the establishment on August 20, 2024, these issues were not satisfactorily resolved by September 18, 2024. The ANSM enjoins Sofibel to establish modalities for managing critical suppliers and subcontractors within 6 months, complete technical documentation for Sterimar devices within 6 months, and define biocharge management modalities within 3 months.

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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