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

Source: https://www.keypedia.com/records/483/university-medical-center-irb/fe12f7af-7a09-49f9-b370-4b6d3b863c2e

> FDA 483 for University Medical Center IRB on November 18, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Medical Center IRB
- Inspection Date: 2022-11-18
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/rebecca-t-davis/a821f7ef-0c73-4be1-9a9b-3fc2c07f88c1)

Company: https://www.keypedia.com/companies/university-medical-center-irb/185b8497-6885-49eb-a84a-64da4bad8f02

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b