FDA 483 - Jennifer W. Leiding M.D. - September 08, 2023

An FDA inspection of Jennifer W. Leiding, Clinical Investigator, in Seminole, FL, revealed significant deficiencies in the conduct of a clinical study. Observations included failures to obtain proper informed consent, report non-serious adverse events to the sponsor, and maintain accurate case histories by reporting all concomitant medications. These issues indicate a concerning lack of adherence to regulatory requirements for human subject protection and data integrity in clinical trials.