FDA 483 - Randy J. Epstein, M.D. - October 26, 2022

Randy J. Epstein, M.D., a sponsor investigator in Highland Park, IL, was cited for significant deficiencies during a clinical investigation. Observations included failure to submit an Investigational New Drug (IND) application, inadequate recordkeeping for the receipt and disposition of investigational drugs, and improper documentation of informed consent. These issues indicate serious non-compliance with regulations governing clinical trials and patient protection.