FDA 483 - St. Peter's University Hospital - CPHSR - February 08, 2019

St. Peter's University Hospital - CFHSR, an Institutional Review Board in New Brunswick, NJ, was inspected by the FDA. The inspection revealed significant deficiencies in the IRB's written procedures for initial and continuing review of research, particularly for medical device studies and Humanitarian Use Devices. Additionally, the IRB failed to maintain meeting minutes with sufficient detail regarding voting records for actions taken.