FDA 483 - Ionisos SAS - November 07, 2024

An FDA Form 483 was issued to a contract sterilizer located in Chaumesnil, France, following an inspection conducted from November 4-7, 2024. The inspection identified two significant observations concerning compliance with regulatory requirements for medical devices intended for the U.S. market. The primary issue, Observation 1, noted that software integral to production was not adequately validated for its intended use, lacking established protocols for validation activities. The firm could not provide evidence of documented protocols for software validation used in processing medical devices. Observation 2 highlighted a failure to properly identify the acceptance status of products. The firm lacked established procedures to clearly distinguish between sterile and non-sterile finished medical devices. This resulted in the commingling of non-sterile and sterile device pallets, and shipping cartons labeled "Sterile" containing devices that had not undergone the sterilization process, without proper identification of their non-sterile status. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act concerning quality system requirements for medical device manufacturing and processing. The firm is responsible for conducting thorough self-audits, implementing comprehensive corrective actions, and providing evidence of these actions to the FDA to address all identified and related quality system deficiencies. The firm reportedly promised to correct Observation 1.