# FDA 483 - Jewish Hospital IRB - October 17, 2019

Source: https://www.globalkeysolutions.net/records/483/jewish-hospital-irb/9c3a1e7d-c44b-44e2-928e-2bcdb96228c5

> FDA 483 for Jewish Hospital IRB on October 17, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jewish Hospital IRB
- Inspection Date: 2019-10-17
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: The Jewish Hospital IRB in Cincinnati, OH, was cited for failing to prepare written procedures for its Institutional Review Board operations. Specifically, the IRB lacked documented procedures for determining which projects require review more than annually and for verifying material changes from sources other than the investigator. This indicates a deficiency in the IRB's procedural controls for oversight of research projects.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marcia-a-worley/bbcc8e30-05b1-4ad4-85da-17209ace9246)

Company: https://www.globalkeysolutions.net/companies/jewish-hospital-irb/f320c0ad-8dd7-4016-a83e-69d9d96cf715

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