483
Wayne State University Institutional Review BoardWayne State University Institutional Review Board – FDA 483, May 8, 2026
Record Details
An FDA inspection of Wayne State University Institutional Review Board in Detroit, MI, revealed a significant issue with the preparation and maintenance of IRB meeting minutes. Specifically, minutes for two meetings were not prepared, maintained, and sent for review according to the established policy. This indicates a lapse in record-keeping practices essential for oversight of human research protection.
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