483
Robert Nelson, M.D., Ph.D.Robert Nelson, M.D., Ph.D. – FDA 483, Oct 23, 2019
Record Details
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.
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ID · 79d88c77-446f-4ac2-b43b-85dda35aed15
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