# FDA 483 - Rachel  H. Epstein, M.D. - March 04, 2022

Source: https://www.globalkeysolutions.net/records/483/rachel-h-epstein-md/55347778-3290-4303-923d-0c428400cadd

> FDA 483 for Rachel  H. Epstein, M.D. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rachel  H. Epstein, M.D.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Rachel H. Epstein, M.D. in Highland Park, IL, a clinical investigator, was cited with three observations during an FDA inspection. The inspection revealed significant issues with adherence to investigational plans, including unperformed protocol assessments and incomplete case histories regarding adverse events and surgical procedures. Additionally, the firm failed to maintain adequate investigational drug disposition records, with instances of drug dispensed prior to subject enrollment and undocumented drug unit dispositions.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/colleen-e-burke/e013131b-6c14-4a60-b3ab-d8759d38624b)

Company: https://www.globalkeysolutions.net/companies/rachel-h-epstein-md/f4a00adc-6e2d-43ad-9356-55ffe1439e43

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