FDA 483 - Sara J Haug, M.D., Ph.D. - April 21, 2023

An FDA inspection of Sara J Haug MD PhD, Clinical Investigator, in Durango, CO, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans and protocols, including issues with patient monitoring, adverse event reporting, investigational product administration, and informed consent. Additionally, the inspection found failures in maintaining adequate and accurate case histories, indicating poor data integrity practices.