FDA 483 - Robert Nelson, M.D., Ph.D. - October 23, 2019

Robert Nelson, M.D., Ph.D. in Phoenix, AZ, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures in following the investigational plan, including enrolling ineligible subjects and not reporting numerous serious adverse events. Additionally, the firm failed to obtain proper informed consent, maintain adequate case histories, and ensure proper study monitoring.