FDA 483 - Steris SA - May 12, 2016

An FDA inspection of Steris SA, a component sterilizer in Brecey, France, revealed a significant issue where written procedures for component testing were not followed. Specifically, air bubbles were observed during microbiological enumeration of components, a condition explicitly prohibited by the firm's own test procedure. This raises concerns about the accuracy and sensitivity of the test method without supporting data.