483
Nicholas Onaca, M.D.Nicholas Onaca, M.D. – FDA 483, Jun 28, 2019
Record Details
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.
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