# FDA 483 - Steven H. Dayan, MD - October 06, 2023

Source: https://www.keypedia.com/records/483/steven-h-dayan-md/d73e3b9b-bd00-4370-bd05-c6c4078fbe32

> FDA 483 for Steven H. Dayan, MD on October 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven H. Dayan, MD
- Inspection Date: 2023-10-06
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Steven H. Dayan, M.D., Clinical Investigator, revealed significant deficiencies in study documentation. The firm failed to properly document informed consent, as subjects did not sign and date consent forms prior to receiving investigational medical devices. Additionally, subject case histories were incomplete, with concomitant medications and medical/surgical histories not fully captured in the electronic case report forms.

## Related Officers

- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.keypedia.com/companies/steven-h-dayan-md/fd5de9b9-d87c-452d-8d5d-fcf45e984b48

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