FDA 483 - University Medical Center IRB - November 18, 2022

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.