# FDA 483 - Somerset Medical Center IRB - March 11, 2026

Source: https://www.keypedia.com/records/483/somerset-medical-center-irb/6c97064b-5d89-4825-8656-5e4b763c54f7

> FDA 483 for Somerset Medical Center IRB on March 11, 2026. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Somerset Medical Center IRB
- Inspection Date: 2026-03-11
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Somerset Medical Center IRB identified significant deficiencies in its Institutional Review Board (IRB) operations. The firm failed to consistently ensure that research approvals received the majority vote of members present, frequently not meeting quorum requirements during convened meetings. These issues involved improper use of e-mail voting to approve research and meeting minutes, indicating systemic non-compliance with IRB procedures.

## Related Documents

- [483 - 2016-09-30](https://www.keypedia.com/records/483/somerset-medical-center-irb/baff3c35-9d69-4222-81ff-9aa5eb908058)
- [EIR - 2016-09-30](https://www.keypedia.com/records/eir/somerset-medical-center-irb/3a956951-0c33-4f1b-9f5a-c9d6dd5aba4d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/somerset-medical-center-irb/fe63c038-95e7-44c8-a93b-f49ec178685e

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248