FDA 483 - Kearney, Susan L., M.D., Clinical Investigator - May 10, 2022

Susan L. Kearney, M.D., Clinical Investigator, was inspected by the FDA from May 2-10, 2022. The inspection revealed a significant issue regarding the oversight of a clinical study, specifically the failure to ensure proper IRB review and reporting of local problems and adverse events. This indicates a serious lapse in regulatory compliance for clinical investigations.