# FDA 483 - University of Texas at Arlington IRB - June 11, 2019

Source: https://www.globalkeysolutions.net/records/483/university-of-texas-at-arlington-irb/5c0098a1-6a8c-42a4-bf03-38bf2e3bac6d

> FDA 483 for University of Texas at Arlington IRB on June 11, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Texas at Arlington IRB
- Inspection Date: 2019-06-11
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of the University of Texas at Arlington IRB identified a significant compliance issue. The Institutional Review Board failed to ensure that informed consent documents included a statement notifying subjects of the possibility of FDA inspection of their study records. This deficiency was noted across multiple reviewed protocols.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/camille-d-brown/419869d2-1810-40ea-8e8a-687de7013f6a)

Company: https://www.globalkeysolutions.net/companies/university-of-texas-at-arlington-irb/b046faed-fab5-4df8-af7b-ba4274839631

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