483
Mount Carmel Health System IRBMount Carmel Health System IRB – FDA 483, Oct 29, 2019
Record Details
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.
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