FDA 483 - Jennifer L. Crombie, M.D. - November 17, 2023

Jennifer L. Crombie, M.D. in Boston, MA was inspected by the FDA from November 13-17, 2023, as a clinical investigator. The inspection revealed a significant deficiency in obtaining legally effective informed consent from study subjects. Specifically, updated informed consent documents were not signed by eight out of ten reviewed subjects, despite IRB approval for the updates and re-consenting plans.