FDA 483 - St. Agnes Medical Center IRB - September 01, 2022

St. Agnes Medical Center IRB received an FDA Form 483 following an inspection conducted from August 29 to September 1, 2022. The inspection identified several deficiencies primarily related to the organization's adherence to regulatory requirements for Institutional Review Boards. Key issues observed include the failure to maintain an accurate and complete list of IRB members, with individuals listed as voting members in meeting minutes not appearing on the official roster. Meeting minutes also lacked sufficient detail, particularly regarding a suspension of operations post-March 2021 and the transfer of responsibilities to another IRB, with no clear documentation of study reviews by the successor IRB. Furthermore, St. Agnes Medical Center IRB failed to report its decision to discontinue reviewing FDA-regulated clinical investigations to the agency within the required timeframe and neglected to renew its IRB registration, which expired in February 2022. The inspection also noted an absence of a clear policy or procedure for determining significant versus non-significant risk for device studies, as required by 21 CFR 812.66. Finally, the facility could not provide essential records, such as informed consent forms and correspondence, for specific studies, failing to maintain records for the mandated three-year period following research completion, as stipulated by 21 CFR 56. These observations indicate a need for comprehensive corrective actions to ensure compliance with FDA regulations.