FDA 483 - Joseph L. Lillo, D.O. - March 22, 2021

An FDA inspection of Joseph L. Lillo, DO, Clinical Investigator, in Phoenix, AZ, from March 15-22, 2021, revealed significant deviations from clinical trial protocols. The investigator failed to conduct an investigation in accordance with the signed statement and investigational plan. Specifically, a subject meeting exclusion criteria was enrolled, and five adverse events were not reported to the sponsor.