Alter Éco Santé

The inspection of Alter Éco Santé's establishment in Villeneuve-Tolosane revealed significant non-conformities and shortcomings. Notified to the establishment on April 30, 2025, these issues were not resolved satisfactorily due to lack of defined and documented procedures for managing suppliers/subcontractors and quality deviations. The French National Agency for Medicine and Health Products Safety (ANSM) ordered Alter Éco Santé to rectify these issues within specified deadlines. The main purpose of the inspection was to ensure compliance with EU medical device regulations, specifically Article 10(9) of Regulation (EU) 2017/745. The inspection revealed a lack of procedures for managing suppliers/subcontractors and quality deviations, which led to non-compliance with EU regulations.