# FDA 483 - Univ CO Boulder Institutional Review Board - July 10, 2019

Source: https://www.globalkeysolutions.net/records/483/univ-co-boulder-institutional-review-board/9fef050d-b2d8-4e68-bc67-f8db4fc5624d

> FDA 483 for Univ CO Boulder Institutional Review Board on July 10, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univ CO Boulder Institutional Review Board
- Inspection Date: 2019-07-10
- Product Type: other
- Office Name: Denver District Office
- Summary: The FDA issued a Form 483 to the University of Colorado at Boulder's Institutional Review Board (IRB) following an inspection. Observations included a lack of written procedures for initial research review, failure to comply with safeguards for children in clinical investigations, and deficiencies in informed consent documents regarding alternate treatments and FDA inspection disclosures. These findings indicate significant issues with the IRB's oversight and documentation practices.

## Related Officers

- [Debra L. Boyd-Seale](https://www.globalkeysolutions.net/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)

Company: https://www.globalkeysolutions.net/companies/univ-co-boulder-institutional-review-board/b2e5fc2f-0047-4506-bde0-e21104c01759

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face