483
University Medical Center IRBUniversity Medical Center IRB – FDA 483, Nov 18, 2022
Record Details
The FDA inspected University Medical Center IRB in Las Vegas, NV, from 11/14/2022 to 11/18/2022. The inspection revealed that IRB meeting minutes were not prepared and maintained with sufficient detail to accurately reflect attendance, actions taken, and voting records for study protocols. This indicates a moderate severity issue related to the proper documentation and oversight of research activities.
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