FDA 483 - Kaohinani Longwolf, MD - August 13, 2025

An FDA inspection of Kaohinani Longwolf, MD, a clinical investigator in Salt Lake City, UT, revealed significant deficiencies in record-keeping and adherence to the investigational plan. Observations included inaccurate and incomplete subject case histories, specifically concerning adverse event assessments, eligibility criteria review, and informed consent procedures. Additionally, the investigation was not conducted according to the protocol, as required baseline lab tests were not completed for all subjects and other tests were performed outside the specified window.