# FDA 483 - Dean Institutional Review Board - March 19, 2018

Source: https://www.keypedia.com/records/483/dean-institutional-review-board/0b15c9f3-5419-4626-90ea-2546ae056b79

> FDA 483 for Dean Institutional Review Board on March 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dean Institutional Review Board
- Inspection Date: 2018-03-19
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection conducted at Dean Institutional Review Board in Madison, WI, from March 12-19, 2018, identified several significant observations concerning their oversight of human subject research. The inspection revealed that the IRB utilized an expedited review process for three studies that did not meet the criteria for such review and had not received prior full board approval. Furthermore, the IRB failed to document its determination of compliance with federal regulations regarding additional safeguards for children in clinical investigations (21 CFR Part 50 Subpart D) for a specific study. Critical procedural gaps were also noted: the IRB lacked written procedures for promptly reporting serious or continuing noncompliance, as well as the suspension or termination of IRB approval, to appropriate institutional officials and the FDA. Lastly, the minutes of IRB meetings were found to be inadequately detailed, specifically from January 2016 to February 2018, lacking consistent voting records and written summaries of discussions on controverted issues. These observations highlight areas where Dean Institutional Review Board must implement corrective actions to ensure full compliance with regulatory requirements for human subject protection.

## Related Officers

- [investigator](https://www.keypedia.com/people/corey-k-reno/f6ff7629-784b-467b-8b5b-2625779d1c1e)

Company: https://www.keypedia.com/companies/dean-institutional-review-board/87200bac-8a26-4d12-9be2-cd6b04c9a22f

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d