FDA 483 - Duke University Children's Hospital and Health Center - August 23, 2017

Duke University Children's Hospital and Health Center in Durham, NC, received a Form FDA-483 citing significant deficiencies in the conduct of clinical investigations, primarily involving the NOOA and STICS studies. Observations included failures to submit required annual reports and protocol changes, obtain investigator statements, adhere to investigational plans for subject eligibility and study procedures, and ensure proper informed consent. Additionally, the firm failed to maintain adequate and accurate case histories.