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483
•University Medical Center IRB•November 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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ID · fe12f7af-7a09-49f9-b370-4b6d3b863c2e

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