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

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.