FDA 483 - Elijah W. Stommel, M.D. - April 11, 2023

An FDA inspection of Elijah W. Stommel, M.D., a sponsor-investigator in Lebanon, NH, revealed nine significant observations related to a clinical study. Key findings included a lapse in IRB approval, failure to obtain proper informed consent, and deviations from the investigational plan. The firm also failed to maintain adequate case histories, submitted late IND annual reports, and had deficiencies in informed consent forms and investigational drug disposition records.