# FDA 483 - Seton Family of Hospitals Institutional Review Board (SFOH IRB) - March 22, 2019

Source: https://www.globalkeysolutions.net/records/483/seton-family-of-hospitals-institutional-review-board-sfoh-irb/63d498a6-a4d3-4d7d-9277-2ce55e649e21

> FDA 483 for Seton Family of Hospitals Institutional Review Board (SFOH IRB) on March 22, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seton Family of Hospitals Institutional Review Board (SFOH IRB)
- Inspection Date: 2019-03-22
- Product Type: other
- Office Name: Dallas District Office
- Summary: An inspection of Seton Family of Hospitals Institutional Review Board (SFOH IRB) in Austin, TX, revealed significant deficiencies in its review processes and recordkeeping. The IRB failed to adequately document pediatric study reviews, conduct timely continuing reviews of ongoing research, and maintain required records due to a catastrophic system failure without proper backup. These issues indicate a lack of robust oversight and data integrity for human subject protection.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/leighton-k-ngai/39fc01c8-e40a-45d4-910a-068955d16a06)

Company: https://www.globalkeysolutions.net/companies/seton-family-of-hospitals-institutional-review-board-sfoh-irb/d1a6b405-85e7-47f6-9180-2b73ad35df67

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9