FDA 483 - Abington Memorial Hospital, IRC - June 18, 2015

An FDA inspection of Abington Memorial Hospital's Institutional Review Board (IRB) in Abington, PA, revealed significant deficiencies in its operations. The inspection identified failures in maintaining proper meeting quorums, establishing written procedures for initial research review, and accurately maintaining IRB member rosters and meeting minutes. Additionally, the IRB was cited for improper expedited review procedures and inadequate reporting of study suspensions or terminations.