GRI

Sofibel 

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 French National Agency for Medicines and Health Products Safety (ANSM) conducted an inspection at Sofibel's Levallois-Perret facility from June 12 to 14, 2024. The inspection revealed significant non-conformities and shortcomings, which were notified to the establishment in a letter on August 20, 2024. The ANSM found insufficient controls over critical suppliers and subcontractors, inadequate technical documentation for the Sterimar product, and insufficient biocharge management. As a result, Sofibel was ordered to establish satisfactory measures within specified timeframes.

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

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