FDA 483 - Nancy A. Krywonis, M.D. - July 23, 2021

An FDA inspection of Nancy A. Krywonis, M.D. in Denver, CO, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans, obtain proper informed consent, ensure IRB oversight for all research sites, and maintain adequate and accurate case histories. These issues indicate a lack of compliance with regulatory requirements for clinical trials.