Barbara E. Rizzardi, MD – FDA 483, Dec 2, 2022

An FDA inspection of Barbara E. Rizzardi, MD, a Principal Investigator in West Jordan, UT, revealed a significant failure to conduct an investigation in accordance with the signed statement of investigator. Specifically, a subject was improperly enrolled in a clinical trial despite having positive serology tests that violated exclusion criteria. This indicates a serious lapse in adherence to study protocols and investigator responsibilities.