FDA 483 - U.S. Investigational Review Board Inc. - June 06, 2022

An FDA inspection of U.S. Investigational Review Board Inc. in Miami, FL, revealed significant deficiencies in its Institutional Review Board operations. Findings included inadequate meeting minutes, improper use of expedited review for studies involving more than minimal risk, and failure to advise IRB members of expedited approvals. Additionally, the firm did not report changes to the types of FDA-regulated products it reviews within the required timeframe.