# FDA 483 - Howard University Institutional Review Board - May 19, 2022

Source: https://www.keypedia.com/records/483/howard-university-institutional-review-board/4ab72752-1ef1-481e-87f6-b872a14277a2

> FDA 483 for Howard University Institutional Review Board on May 19, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Howard University Institutional Review Board
- Inspection Date: 2022-05-19
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: The FDA issued a Form 483 to Howard University Institutional Review Board following an inspection from May 11-19, 2022. The inspection revealed a significant deficiency in the preparation of IRB meeting minutes, specifically regarding the accurate documentation of attendance. Discrepancies were noted between the number of members recorded as present and the number participating in votes across multiple meetings.

## Related Officers

- [investigator](https://www.keypedia.com/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)

Company: https://www.keypedia.com/companies/howard-university-institutional-review-board/308d0f89-3c36-4ddc-990d-fb0125b565a4

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64