FDA 483 - James Melvin Rajan, M.D. - October 26, 2023

James Melvin Rajan, M.D. in Canton, OH, a Principal Investigator, was cited for significant failures in maintaining study records during an FDA inspection. The inspection revealed a lack of informed consent documents and study source records for subjects who were consented, screened, treated, or transferred, including two subjects who reportedly died. These deficiencies indicate a serious breakdown in the integrity of clinical trial documentation.