# FDA 483 - Kent L. Wellish, M.D. - February 13, 2023

Source: https://www.keypedia.com/records/483/kent-l-wellish-md/07f15304-7832-4a83-bab7-a84fd678e063

> FDA 483 for Kent L. Wellish, M.D. on February 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kent L. Wellish, M.D.
- Inspection Date: 2023-02-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Kent L. Wellish, M.D. in Las Vegas, NV, a clinical investigator, was cited for significant deviations from a clinical study protocol during an FDA inspection. The inspection revealed multiple instances of non-compliance, including enrolling a subject who met exclusion criteria, failing to perform required examinations and vital sign measurements, and inadequate documentation and reporting of adverse events and protocol deviations. These issues indicate a lack of adherence to good clinical practice and the signed investigator statement.

## Related Officers

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

Company: https://www.keypedia.com/companies/kent-l-wellish-md/d80778cd-9450-4e54-b47f-ff9537f29c21

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