FDA 483 - Memorial Hospital of Rhode Island IRB - April 17, 2019

An FDA inspection of Memorial Hospital of Rhode Island IRB in Pawtucket, RI, identified a significant deficiency in the maintenance of Institutional Review Board (IRB) meeting minutes. The IRB failed to adequately document voting actions for FDA-regulated studies, indicating a lapse in record-keeping procedures. This observation highlights a need for improved detail in recording IRB decisions and votes.