FDA 483 - Jeffrey R. Hoodin, M.D. - March 13, 2026

From March 9 to March 13, 2026, the FDA conducted an inspection of the clinical research facility of Jeffrey R. Hoodin, M.D., in Phoenix, Arizona. The inspection revealed significant concerns regarding the integrity of study data and adherence to research protocols. Key violations included the failure to maintain accurate case histories, with evidence of unauthorized staff performing assessments reserved for the lead investigator. The FDA also identified contradictory records regarding whether specific medical procedures were performed on participants and noted that eligibility documentation was frequently completed or altered weeks after subjects were already enrolled and randomized. In some instances, the investigator certified participant eligibility before receiving essential laboratory results.

Additionally, the facility failed to follow the specific investigational plan by enrolling participants who did not meet health criteria and neglecting to adjust medication dosages as required by the study protocol. These findings were issued under the Federal Food, Drug, and Cosmetic Act to assist the firm in reaching compliance. While the report does not constitute a final agency determination, the investigator is expected to respond by documenting corrective actions or providing explanations for the observed deficiencies to ensure future participant safety and data reliability.