483
St. Peter's University Hospital - CPHSRSt. Peter's University Hospital - CPHSR – FDA 483, Jul 4, 2019
Record Details
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.
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