University Medical Center IRBNovember 18, 2022

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

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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.

Company: University Medical Center IRB
Inspection Date: November 18, 2022
Product Type: Other
Office: Division of Human and Animal Food Operations - West V
Person: Rebecca T. Davis (investigator)

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