# FDA 483 - Mount Sinai School of Medicine - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/mount-sinai-school-of-medicine/b36cd63f-41e3-495f-93e8-33504e5ab605

> FDA 483 for Mount Sinai School of Medicine on Unknown Date. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mount Sinai School of Medicine
- Product Type: other
- Office Name: New York District Office
- Summary: An FDA inspection of the Institutional Review Board (IRB) at Mount Sinai School of Medicine in New York revealed multiple deficiencies related to IRB meeting procedures and membership. Observations included a lack of a non-scientific member at a meeting, absence of voting records, and issues with quorum and the designation and voting practices of alternate members. These findings indicate a failure to adhere to proper IRB operational guidelines.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/thomas-p-hansen/2b3af3e0-445c-460b-be6f-6db03999ff7e)

Company: https://www.globalkeysolutions.net/companies/mount-sinai-school-of-medicine/4b038d3b-7fe4-4a05-9c92-93aae24dcd54

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d