FDA 483 - Mount Carmel Health System IRB - October 29, 2019

An FDA inspection of Mount Carmel Health System IRB in Columbus, OH, revealed significant deficiencies in their Institutional Review Board (IRB) operations. The inspection found that IRB meeting minutes lacked sufficient detail regarding actions taken and that the IRB improperly used expedited review procedures for changes that were not minor in nature. These findings indicate a need for improved documentation and adherence to review protocols.