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

An FDA inspection of Jeffrey R. Hoodin, M.D. in Phoenix, AZ, identified significant non-compliance in a clinical investigation. The principal investigator failed to maintain adequate and accurate case histories, including issues with unauthorized personnel reviewing assessments, conflicting documentation, and delayed eligibility determinations. Furthermore, the firm enrolled ineligible subjects and did not adhere to protocol requirements for managing concomitant medications.