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

St. Agnes Medical Center IRB in Fresno, CA, was cited for multiple deficiencies related to its operations and record-keeping during an FDA inspection. The observations highlight failures in maintaining accurate IRB member rosters, detailed meeting minutes, and proper reporting to the FDA regarding operational changes and discontinuation. Additionally, the IRB did not renew its registration, lacked policies for device risk determinations, and failed to retain required research records.