Injunction n ° 2024-dm-div-020-inj of 03/06/2025 relating to the establishment of the company AD Nucleis located in Grézieu La Varenne (Rhône) at 24b rue du Stade-Park Cap Ouest

The inspection of AD NUCLEIS' establishment in Grézieu La Varenne (Rhône) revealed significant non-conformities and shortcomings. These were notified to the company in a letter prior to injunction on January 10, 2025, with additional information provided on May 9, 2025. The inspection highlighted several areas of concern, including incomplete data for device descriptions and specifications, conception and fabrication details, risk management, performance studies, stability studies, labeling, and equipment maintenance. The ANSM has issued injunctions to AD NUCLEIS to address these issues within specified timeframes, ranging from 3 to 12 months. The company is required to complete documentation, provide data on device design and manufacturing, establish a risk management plan, conduct performance validation, update labeling and notices, ensure equipment maintenance, and guarantee traceability. Failure to comply may have significant implications for the industry and the company's reputation.