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

An FDA inspection was conducted at Saint Bernards Medical Center IRB in Jonesboro, AR, from May 25-26, 2022. The inspection resulted in a Form FDA 483 observation concerning the organization's record-keeping practices for its Institutional Review Board (IRB) meetings. The main issue identified was that minutes from IRB meetings, specifically those spanning from 2019 to 2022, were not prepared and maintained with sufficient detail to accurately document attendance. Critically, these records failed to identify all individual members who voted during meetings. Instead, the minutes only noted the total number of voting members present, a count that was occasionally inaccurate. This finding highlights a lapse in adhering to regulatory expectations for IRBs, which are crucial for overseeing research involving human subjects under the Federal Food, Drug, and Cosmetic Act. While a Form FDA 483 is an observation document and not a final determination of non-compliance, it signals the need for the firm to review and enhance its procedural controls. Saint Bernards Medical Center IRB is expected to evaluate this observation and implement appropriate corrective actions to ensure that future meeting minutes are comprehensive and accurately reflect member participation and voting records, thereby upholding the integrity of the review process.