# FDA 483 - Mt. Sinai Hospital Medical Center IRB - May 26, 2023

Source: https://www.globalkeysolutions.net/records/483/mt-sinai-hospital-medical-center-irb/a9ff1e68-fbb3-4514-b2f9-e129b60459f2

> FDA 483 for Mt. Sinai Hospital Medical Center IRB on May 26, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mt. Sinai Hospital Medical Center IRB
- Inspection Date: 2023-05-26
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Mt. Sinai Hospital Medical Center IRB in Chicago, IL, revealed a significant deficiency in maintaining adequate records. The Institutional Review Board failed to prepare and maintain detailed minutes for several meetings where FDA-regulated studies were reviewed. This indicates a serious lapse in documentation practices for research oversight.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)

Company: https://www.globalkeysolutions.net/companies/mt-sinai-hospital-medical-center-irb/6af3ef59-7f70-435e-bd5c-c935bcd88bff

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