483
Ascension Sacred Heart Hospital IRBAscension Sacred Heart Hospital IRB – FDA 483, Aug 10, 2022
Record Details
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.
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ID · c6976d27-5183-4d9f-845d-026535967ebc
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