# FDA 483 - Mount Carmel Health System IRB - October 29, 2019

Source: https://www.keypedia.com/records/483/mount-carmel-health-system-irb/ce2d2c1f-c111-4212-9aa0-e0fa01956fc6

> FDA 483 for Mount Carmel Health System IRB on October 29, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mount Carmel Health System IRB
- Inspection Date: 2019-10-29
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Mount Carmel Health System IRB in Columbus, OH, revealed significant deficiencies in their Institutional Review Board (IRB) operations. The inspection found that IRB meeting minutes lacked sufficient detail regarding actions taken and that the IRB improperly used expedited review procedures for changes that were not minor in nature. These findings indicate a need for improved documentation and adherence to review protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.keypedia.com/companies/mount-carmel-health-system-irb/6cc36f3d-1bea-4974-98c8-90b528378939

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22