FDA 483 - Innovative Sterilization Technologies LLC - January 13, 2022

Innovative Sterilization Technologies LLC in Dayton, OH, a medical device manufacturer, was cited with two observations during an FDA inspection from December 2021 to January 2022. The inspection revealed deficiencies in the firm's risk analysis procedures, specifically regarding the completeness of risk assessments for their ONE TRAY and Process Kits. Additionally, the firm's design change procedures were found to be inadequate, lacking established verification expectations prior to the approval of Engineering Change Notifications.