# FDA 483 - Columbia University Medical Center IRB - August 31, 2022

Source: https://www.keypedia.com/records/483/columbia-university-medical-center-irb/58ce8616-0528-414c-ab6b-9380ffdfc176

> FDA 483 for Columbia University Medical Center IRB on August 31, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Columbia University Medical Center IRB
- Inspection Date: 2022-08-31
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Columbia University Medical Center IRB, an Institutional Review Board in New York, NY, was cited with a Form 483 for deficiencies in its operations. The inspection revealed that the IRB did not consistently ensure the presence of a nonscientific member or meet quorum requirements during convened meetings for FDA-regulated research. Furthermore, the firm failed to maintain adequate meeting minutes, specifically lacking sufficient detail on attendance and voting records.

## Related Officers

- [investigator](https://www.keypedia.com/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)
- [Omadevi Somai](https://www.keypedia.com/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)
- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)
- [Jonathan D Green](https://www.keypedia.com/people/jonathan-d-green/fbc0d812-f5a0-49fb-9bec-2c4419206fb4)

Company: https://www.keypedia.com/companies/columbia-university-medical-center-irb/cce93871-8b9d-4226-83df-f11ea120e828

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961