# FDA 483 - Somerset Medical Center IRB - September 30, 2016

Source: https://www.globalkeysolutions.net/records/483/somerset-medical-center-irb/baff3c35-9d69-4222-81ff-9aa5eb908058

> FDA 483 for Somerset Medical Center IRB on September 30, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Somerset Medical Center IRB
- Inspection Date: 2016-09-30
- Product Type: other
- Office Name: New Jersey District Office
- Summary: The FDA inspected Somerset Medical Center IRB in Somerville, NJ, and found significant deficiencies in its operations. The inspection revealed multiple failures related to IRB member conduct, meeting procedures, and record-keeping practices. These issues indicate a systemic lack of adherence to regulatory requirements and the IRB's own written procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/denise-m-visco/14fa6a3e-8d0c-4098-ae13-3575c0332394)

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

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