FDA 483 - Vanderbilt University Medical Center RDRC - April 01, 2015

An FDA inspection of Vanderbilt University Medical Center RDRC in Nashville, TN, identified a significant delay in reporting research proposals to the FDA. The firm failed to immediately report two studies involving more than thirty subjects, with reporting delays of 37 and 36 calendar days after approval. This indicates a lapse in regulatory compliance regarding the timely submission of research study approvals.