# FDA 483 - Meharry Medical College Institutional Review Board - November 02, 2021

Source: https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/26655b58-51a6-4cb5-b375-b1236b3a20be

> FDA 483 for Meharry Medical College Institutional Review Board on November 02, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Meharry Medical College Institutional Review Board
- Inspection Date: 2021-11-02
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA Form 483 was issued to an Institutional Review Board (IRB) located in Bethesda, MD, following an inspection conducted from October 20 to November 20, 2021. The inspection revealed several significant observations regarding the IRB’s operations, falling under the regulatory framework for human subject protection. The primary issues identified revolved around inadequate documentation and adherence to established procedures. Specifically, the IRB failed to prepare and maintain meeting minutes with sufficient detail. These deficiencies included a lack of comprehensive records detailing attendance, specific IRB actions, individual voting outcomes (for, against, abstaining members), and the rationale behind requiring changes in or disapproving research. Furthermore, written summaries of discussions for controversial issues and their resolutions were found to be insufficient. The inspection also noted that the IRB did not consistently follow its own written procedures for both initial and continuing review processes. This included insufficient documentation of reviewer activities for expedited and continuing reviews, such as failing to record when an alternate member voted, and lacking detailed information on assigned reviewers or expert consultants for agenda items. There was also a notable inconsistency in documenting voting actions, with records failing to properly identify members who abstained or were recused. In response to these observations, the IRB is required to submit a comprehensive response to the FDA. This response must outline planned or implemented corrective actions to address each identified deficiency, or provide justification and objections to the findings, ensuring future compliance with federal regulations governing IRBs.

## Related Documents

- [483 - 2021-11-02](https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/b9b522c5-83cb-4259-9cf3-78ff65e40711)
- [483 - 2021-11-04](https://www.keypedia.com/records/483/meharry-medical-college-institutional-review-board/4cd95ed3-6296-40cf-8903-bf1a63470843)

## 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