FDA 483 - Robert Joseph Jeanfreau, MD - February 25, 2022

Robert Joseph Jeanfreau, MD, a clinical investigator in Metairie, LA, was cited for significant deficiencies during a clinical investigation inspection. Observations included failure to conduct a study according to the investigational plan, specifically enrolling a vaccinated subject and administering an incorrect investigational product. Additionally, the firm failed to maintain adequate and accurate case histories, leading to the enrollment of an ineligible subject.