# FDA 483 - Rush University Medical Center IRB - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-irb/3db1a6ab-e2a6-4d87-8456-bef08d47f021

> FDA 483 for Rush University Medical Center IRB on September 12, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rush University Medical Center IRB
- Inspection Date: 2025-09-12
- Product Type: other
- Office Name: Chicago District Office
- Summary: Rush University System for Health IRB in Chicago, IL, was inspected by the FDA, revealing a significant deficiency in their informed consent process. The IRB failed to ensure that informed consent documents for multiple studies included a statement notifying participants of the possibility of FDA record inspection. This indicates a compliance issue related to human subject protection regulations.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)
- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.globalkeysolutions.net/companies/rush-university-medical-center-irb/b9bb7c92-cb60-474d-822d-9eedaef36d40

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