# FDA 483 - U.S. Investigational Review Board Inc. - June 06, 2022

Source: https://www.globalkeysolutions.net/records/483/us-investigational-review-board-inc/97aa7ac9-897b-4abd-9f69-de66fe4b82a6

> FDA 483 for U.S. Investigational Review Board Inc. on June 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: U.S. Investigational Review Board Inc.
- Inspection Date: 2022-06-06
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of U.S. Investigational Review Board Inc. in Miami, FL, revealed significant deficiencies in its Institutional Review Board operations. Findings included inadequate meeting minutes, improper use of expedited review for studies involving more than minimal risk, and failure to advise IRB members of expedited approvals. Additionally, the firm did not report changes to the types of FDA-regulated products it reviews within the required timeframe.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)
- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.globalkeysolutions.net/companies/us-investigational-review-board-inc/2f200d8b-bd87-4e07-bcdf-57c9054d356c

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6