# FDA 483 - Meharry Medical College Institutional Review Board - November 04, 2021

Source: https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/4cd95ed3-6296-40cf-8903-bf1a63470843

> FDA 483 for Meharry Medical College Institutional Review Board on November 04, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meharry Medical College Institutional Review Board
- Inspection Date: 2021-11-04
- Product Type: other
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Meharry Medical College Institutional Review Board in Nashville, TN, revealed significant deficiencies in the preparation and maintenance of IRB meeting minutes. The firm failed to maintain sufficient detail regarding attendance, actions, and voting records, and did not adequately document review and approval processes for research protocols. Additionally, the IRB did not consistently follow its own written procedures for conducting initial and continuing research reviews, particularly concerning the documentation of alternate voters and designated reviewers.

## Related Documents

- [483 - 2021-11-02](https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/b9b522c5-83cb-4259-9cf3-78ff65e40711)
- [483 - 2021-11-02](https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/26655b58-51a6-4cb5-b375-b1236b3a20be)

## Related Officers

- [Consumer Safety Officer/Investigator](https://www.keypedia.com/people/donna-d-gallien/3b5d4a2b-4c8b-4618-a986-3a23c12faad4)

Company: https://www.keypedia.com/companies/meharry-medical-college-institutional-review-board/3e3812f1-1e7e-4561-825e-69d019d33240

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea