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

An FDA inspection of Ascension Sacred Heart Hospital IRB in Pensacola, FL, revealed a significant issue with record maintenance. The Institutional Review Board failed to properly maintain records required by 21 CFR 56, specifically regarding the identification of IRB voting members by name and representative capacity for several years. This indicates a moderate severity finding related to regulatory compliance for IRB operations.