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

Source: https://www.keypedia.com/records/483/us-investigational-review-board-inc/10a696be-dbe7-444e-aa2d-5a53e6232040

> FDA 483 for U.S. Investigational Review Board Inc. on June 06, 2022. Product: devices. 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: devices
- Office Name: Florida District Office
- Summary: An FDA inspection of U.S. Investigational Review Board Inc., conducted from June 1 to June 6, 2022, identified several significant issues related to its operations. The inspection found that minutes of IRB meetings were frequently inadequate or inaccurate, lacking details on actions taken, conflicting approval dates, or failing to document critical risk assessments for medical devices across five of six reviewed studies. A notable observation was the improper use of expedited review procedures for studies that clearly posed more than minimal risk to human subjects, such as those involving tissue harvesting and reinjection, which should have undergone full board review. The firm also failed to consistently inform its full IRB membership about research proposals approved through expedited review processes. Additionally, U.S. Investigational Review Board Inc. did not promptly report changes to the types of FDA-regulated products it reviews, having overseen various drugs and medical devices since 2019 without updating its registration. These findings indicate a need for the company to implement comprehensive corrective actions to ensure meticulous record-keeping, accurate risk assessments, adherence to review procedures, and timely regulatory updates to maintain compliance with FDA regulations governing Institutional Review Boards.

## Related Documents

- [483 - 2022-06-06](https://www.keypedia.com/records/483/us-investigational-review-board-inc/97aa7ac9-897b-4abd-9f69-de66fe4b82a6)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)
- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)
- [President at Genpact](https://www.keypedia.com/people/damon-a-growl/b2827f8c-e454-4db3-9285-07d11b964d5a)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9