# FDA 483 - Trinity Hospital IRB # 1 - October 11, 2019

Source: https://www.keypedia.com/records/483/trinity-hospital-irb-1/3c40f2f9-5b0b-4076-9b60-3fad87fbdd92

> FDA 483 for Trinity Hospital IRB # 1 on October 11, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Trinity Hospital IRB # 1
- Inspection Date: 2019-10-11
- Product Type: other
- Office Name: Dallas District Office
- Summary: Trinity Hospital IRB # 1 in Minot, ND, received a Form 483 with two observations during an FDA inspection. The observations highlight that the Institutional Review Board failed to adequately review research protocols and did not consistently maintain a quorum at convened meetings for non-expedited research. These findings indicate non-compliance with regulatory requirements for IRB operations.

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- [CSO](https://www.keypedia.com/people/andrea-a-branche/9ffe9b53-7963-49a6-be4e-25e644f1759f)

Company: https://www.keypedia.com/companies/trinity-hospital-irb-1/ce1ef5ec-97a8-48dc-8af7-7d8fcdfc9406

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