# FDA 483 - Summa Health System IRB - October 07, 2020

Source: https://www.keypedia.com/records/483/summa-health-system-irb/e4ff16c9-7f93-438c-8510-5f2dc2ee2009

> FDA 483 for Summa Health System IRB on October 07, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summa Health System IRB
- Inspection Date: 2020-10-07
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Summa Health System IRB in Akron, OH, revealed a significant deficiency concerning its Institutional Review Board operations. The firm failed to establish written procedures for the implementation and management of a central IRB, despite utilizing one since 2018. This lack of documentation impacts critical aspects of research review, reporting, and compliance with regulations for human subject protection.

## Related Officers

- [investigator](https://www.keypedia.com/people/craig-t-rybus/246aad79-6370-42e2-af6e-c0079c1bcbc6)

Company: https://www.keypedia.com/companies/summa-health-system-irb/b7fc8e86-940f-4ac7-947f-bb18a59f976b

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