FDA 483 - Mark Fesler, M.D. - May 23, 2025

Saint Lukes Hospital in Chesterfield, MO, was cited for significant deficiencies in conducting clinical trials. Observations included failure to follow investigational plans, enrolling ineligible subjects, issues with investigational medical product dosing and vital sign collection, and critical failures in reporting both serious and non-serious adverse events to the sponsor. These issues indicate a lack of adherence to clinical trial protocols and regulatory requirements.