FDA 483 - Edward Fox, M.D. - March 24, 2023

Edward Fox, M.D., a clinical investigator in Round Rock, TX, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed significant deviations, including inadequate reporting and evaluation of a subject's pregnancy and insufficient documentation for evaluating abnormal safety lab results for another subject. These findings indicate a lack of adherence to study protocols and proper subject safety monitoring.