Sirona-Pharma Ordered to Address Compliance Failures

The inspection of SIRONA-PHARMA's establishment in Maine-et-Loire revealed significant non-conformities and shortcomings. Notified on December 13, 2024, these issues included non-compliance with public service obligations, quality management, and export regulations. The ANSM enjoined the society to rectify these issues within specific deadlines, focusing on: * Meeting public service obligations within a month * Complying with the system of inter-enterprise standby within a month * Implementing measures for quality management, personal practice, and responsibility within a month * Ceasing exports until public service obligations are met within 8 days Compliance considerations include adherence to regulations on exportation, quality management, and public service obligations.