FDA 483 - Robert L. Tychsen, MD - March 11, 2022

An FDA inspection of Robert L. Tychsen, MD, a clinical investigator in St Louis, MO, revealed significant deficiencies in the protection of human subjects. Observations included failures to obtain informed consent prior to study procedures and discrepancies in the documentation of consent. Additionally, subject case history records were found to be inaccurate or incomplete, with issues regarding original consent forms and participant identification.