FDA 483 - Saint Bernards Medical Center IRB - May 26, 2022

An FDA inspection of Saint Bernards Medical Center IRB in Jonesboro, AR, revealed an issue with the preparation and maintenance of IRB meeting minutes. Specifically, the minutes from 2019-2022 did not sufficiently detail attendance, failing to identify all voting members and sometimes inaccurately reporting the number of voting members present. This indicates a deficiency in record-keeping practices for the Institutional Review Board.