FDA 483 - Janet Thomas, M.D. - November 27, 2017

Children's Hospital Colorado in Aurora, CO, was cited for significant deficiencies in its clinical investigations. Observations included failures to adhere to investigator statements regarding subject eligibility, dietary monitoring, and self-administration competency. Additionally, the firm failed to maintain adequate and accurate case histories, leading to unreported adverse events and inconsistent documentation. Informed consent documents also lacked descriptions of foreseeable risks related to required study supplements.