FDA 483 - Lisa A. Clough, M.D. - April 18, 2023

Lisa A. Clough, M.D., a clinical investigator in Kansas City, KS, was cited for failing to conduct an investigation in accordance with the investigational plan. Specifically, the firm did not ensure that study subjects met all required inclusion criteria, including providing sufficient proof of pregnancy status eligibility for a participant. This indicates a significant deviation from protocol adherence in clinical research.