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

Source: https://www.globalkeysolutions.net/records/483/randy-j-epstein-md/fc4da6b9-7bb7-472a-8e25-a83140ae8c95

> FDA 483 for Randy J. Epstein, M.D. on October 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Randy J. Epstein, M.D.
- Inspection Date: 2022-10-26
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/lisa-hayka/a8ca35f8-88e2-4dfb-9881-82f0ac7db8bf)
- [investigator](https://www.globalkeysolutions.net/people/colleen-e-burke/e013131b-6c14-4a60-b3ab-d8759d38624b)

Company: https://www.globalkeysolutions.net/companies/randy-j-epstein-md/6ca248b5-976a-4dc6-873a-ac6f7aad42fc

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669