Val R. Hansen, M.D. – FDA 483, Sep 3, 2021

Val R. Hansen, MD, a Clinical Investigator in Bountiful, UT, was cited for significant deviations from an investigational plan and inadequate record-keeping. Observations included failing to conduct subject visits within required windows and insufficient oversight of study staff regarding serious adverse event reporting. Additionally, the firm failed to maintain accurate case histories, evidenced by incorrect lab review dates and missing source documents.