FDA 483 - Leonard Appleman, M.D, PhD - June 14, 2021

Leonard Appleman, M.D, PhD, a clinical investigator in Pittsburgh, PA, was cited for significant deficiencies during an FDA inspection. The inspection revealed failures to conduct an investigation according to the signed statement and investigational plan, including issues with reporting serious and non-serious adverse events and concomitant medications. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the reporting of the primary study endpoint.