# FDA 483 - Jean F. Botha, M.D. - February 07, 2025

Source: https://www.globalkeysolutions.net/records/483/jean-f-botha-md/af558d4b-deec-4c16-b917-6f9931a53afc

> FDA 483 for Jean F. Botha, M.D. on February 07, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jean F. Botha, M.D.
- Inspection Date: 2025-02-07
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Jean F. Botha, M.D., a clinical investigator in Murray, UT, revealed significant deviations from the investigational plan. The firm failed to reconsent subjects with updated informed consent versions and did not conduct required direct patient contact visits as stipulated by an amended Clinical Investigation Plan. These issues indicate a lack of adherence to study protocols and subject protection.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/jean-f-botha-md/7c61d97e-1db8-45fd-a842-214ae029dc68

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face