Randy J. Epstein, M.D.October 26, 2022

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

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Record Details

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.

Company: Randy J. Epstein, M.D.
Inspection Date: October 26, 2022
Product Type: Drugs
Office: Chicago District Office
People: Lisa Hayka (investigator)
Colleen E. Burke (investigator)

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ID · fc4da6b9-7bb7-472a-8e25-a83140ae8c95