FDA 483 - Martin T. Taylor, DO, PhD - September 27, 2022

An FDA inspection of Martin T. Taylor, DO, PhD in New Albany, OH, revealed significant deviations from the investigational plan for protocol M15-736. Issues included enrolling an ineligible subject, failing to report serious adverse events to the sponsor in a timely manner, and allowing unqualified study coordinators to perform critical screening and adverse event assessments. These findings indicate serious concerns regarding the integrity and safety of the clinical trial conduct.