FDA 483 - Ionisos SAS - November 07, 2024

An FDA inspection of ionisos SAS, a contract sterilizer in Chaumesnil, France, revealed two significant observations. The firm failed to adequately validate software used in medical device production and could not provide documented protocols for these activities. Additionally, the acceptance status of medical devices was not properly identified, leading to the commingling of sterile and non-sterile products and potential distribution of unsterilized devices labeled as sterile.