483
Nicholas Onaca, M.D.FDA 483 - Nicholas Onaca, M.D. - June 28, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · f4995b7c-4b5e-4822-bf03-dc87ddd34899