# FDA 483 - R. Doyle Stulting, MD - August 18, 2023

Source: https://www.globalkeysolutions.net/records/483/r-doyle-stulting-md/affed33f-6f4d-4405-8a36-b8e3092b11a8

> FDA 483 for R. Doyle Stulting, MD on August 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: R. Doyle Stulting, MD
- Inspection Date: 2023-08-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of R. Doyle Stulting, MD, a sponsor-investigator, revealed significant deficiencies in clinical trial conduct. Observations included the failure to report numerous non-serious adverse events to the sponsor, failure to submit two annual reports to the FDA, and failure to obtain IRB approval for a change in principal investigator prior to implementation. These findings indicate a lack of adherence to regulatory requirements for clinical research.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.globalkeysolutions.net/companies/r-doyle-stulting-md/d714b48d-d12b-4a51-ab57-ed8f21f8e50d

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7