FDA 483 - Shannon R. Schrader, M.D. - March 03, 2020

Research Access Network in Houston, TX, was cited for significant deficiencies in its clinical trial conduct. Observations included failures to follow the investigator's statement regarding subject procedures and visits, inadequate investigational drug disposition records, and a critical failure to obtain proper informed consent from human subjects. These issues indicate a lack of adherence to study protocols and regulatory requirements.