FDA 483 - Abington Memorial Hospital, IRC - February 15, 2019

Abington Memorial Hospital, IRC, an Institutional Review Board (IRB) in Abington, PA, was inspected by the FDA from February 11-15, 2019. The inspection revealed three significant issues related to IRB meeting documentation, adherence to expedited review procedures, and proper composition of convened meetings for non-expedited research. One finding regarding meeting minutes was a repeat observation from a previous inspection.