Brief

The inspection of Safir Dentaire's establishment in Saint Herblain (44) revealed significant non-conformities and shortcomings. Notified to the establishment on March 4, 2025, these issues were not resolved satisfactorily by the establishment's responses between March 14 and 27. The ANSM has instructed Safir to implement a reliable, permanent, and secure data backup system within three months; establish a validated list of manufacturers and, as applicable, mandatories and importers for all devices made available by the establishment within one month. Additionally, specific systems and measures must be implemented to address deficiencies in device traceability, stock management, and complaint handling.

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

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