FDA 483 - Nicholas Onaca, M.D. - June 28, 2019

An FDA inspection of Nicholas Onaca, M.D., a clinical investigator in Dallas, TX, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, multiple subjects were consented, screened, and randomized into a study despite not meeting the established inclusion/exclusion criteria. This indicates significant deviations from the study protocol during subject enrollment.