# FDA 483 - Georgetown University IRB - March 11, 2020

Source: https://www.keypedia.com/records/483/georgetown-university-irb/4722f8c4-e3d7-4442-83cf-0c475868fe7f

> FDA 483 for Georgetown University IRB on March 11, 2020. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Georgetown University IRB
- Inspection Date: 2020-03-11
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Georgetown University IRB was inspected by the FDA from March 4-11, 2020, regarding its Institutional Review Board operations. The inspection revealed significant deficiencies in the preparation and maintenance of IRB meeting minutes, specifically concerning attendance records, vote tallies, and potential conflicts of interest. These issues indicate a lack of detailed documentation necessary to ensure proper oversight of research protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)
- [investigator](https://www.keypedia.com/people/john-dan/8a8c42e4-66ec-438d-868e-f32461f9026c)

Company: https://www.keypedia.com/companies/georgetown-university-irb/b195ba2d-0ef0-4c37-9bc9-b100223ce0a4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e