# FDA 483 - Morris Hospital and  Silver Cross Hospital IRB - March 16, 2020

Source: https://www.keypedia.com/records/483/morris-hospital-and-silver-cross-hospital-irb/70f8315e-7507-4104-8b11-e189217397cb

> FDA 483 for Morris Hospital and  Silver Cross Hospital IRB on March 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morris Hospital and  Silver Cross Hospital IRB
- Inspection Date: 2020-03-16
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection conducted on March 12, 13, and 16, 2020, at Morris Hospital & Silver Cross Hospital IRB, identified significant deficiencies in their operations. The regulatory body issued a Form FDA 483, detailing four key observations regarding compliance with federal regulations for Institutional Review Boards. The primary issues included a lack of written procedures for promptly reporting serious or continuing noncompliance to the FDA, and a similar absence of procedures for reporting the suspension or termination of IRB approvals. Furthermore, the inspection revealed that for non-expedited reviews, the IRB did not consistently conduct reviews at properly convened meetings, specifically failing to ensure a majority of members were present, including a non-scientific member, and that all members properly voted. Lastly, the IRB allowed members with a conflicting interest to participate in and vote on the continuing review of FDA-regulated studies. To address these findings, Morris Hospital & Silver Cross Hospital IRB is expected to develop and implement robust written procedures, ensure adherence to meeting quorum requirements, and enforce strict conflict of interest policies.

## Related Officers

- [Debra L. Boyd-Seale](https://www.keypedia.com/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)
- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/morris-hospital-and-silver-cross-hospital-irb/cda95575-39f0-4954-ac2a-fc34d535287f

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