FDA 483 - St. Peter's University Hospital - CPHSR - July 04, 2019

An FDA inspection of St. Peter's University Hospital - CFHSR, an Institutional Review Board in New Brunswick, revealed significant deficiencies in its operations. The inspection found that the IRB lacked written procedures for conducting initial and continuing reviews of research, particularly for medical device studies and Humanitarian Use Devices. Additionally, the IRB failed to maintain meeting minutes with sufficient detail regarding voting actions.