FDA 483 - Ascension Sacred Heart Hospital IRB - August 10, 2022

Ascension Sacred Heart Hospital IRB received an FDA Form 483 following an inspection conducted from August 8 to August 10, 2022. The inspection identified a significant observation related to the maintenance of required records, specifically concerning their Institutional Review Board (IRB) operations. The primary issue cited was that the organization failed to maintain records as mandated by 21 CFR Part 56, which governs IRBs. Specifically, the IRB Voting Members list for the years 2019 through 2022 did not adequately identify board members by name and their respective representative capacities. This lack of detailed record-keeping prevents proper verification of IRB composition and member roles as required by federal regulations. This observation indicates a deficiency in the IRB's adherence to regulatory standards for documentation. Ascension Sacred Heart Hospital IRB is expected to evaluate this observation, develop, and implement appropriate corrective and preventive actions to ensure full compliance with 21 CFR Part 56 regarding record maintenance for all future and past research activities. The FDA 483 serves as a formal communication of these inspectional findings, prompting the facility to address the identified issues.