GRI

Injunction No. 2025-OTC-007-INJ relating to the Dental Austral Group establishment located in Piton Saint-Leu (La Réunion), 21 rue de l’Usine

Enforcement Healthcare & Pharma Sanctions & Fines
Date: 4th Aug, 2025 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

The inspection of Dental Austral Group's establishment in La Réunion revealed significant non-conformities and deficiencies. A letter was sent to the establishment on June 3, 2025, outlining the identified issues. The ANSM has issued injunctions for the establishment to implement various measures within specified timeframes to address these concerns. The main purpose of the inspection is to ensure compliance with health regulations. The industry impact involves a comprehensive overhaul of quality management systems and staff training. Compliance considerations include implementing procedures for modification governance, quality management, employee training, product tracing, and software security within stipulated deadlines.

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

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