# FDA 483 - Essex Institutional Review Board, Inc - March 21, 2011

Source: https://www.keypedia.com/records/483/essex-institutional-review-board-inc/fb79fcd3-425e-4d03-bf71-c1bcd9348e23

> FDA 483 for Essex Institutional Review Board, Inc on March 21, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Essex Institutional Review Board, Inc
- Inspection Date: 2011-03-21
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Essex Institutional Review Board, Inc. in Lebanon, NJ, revealed significant deficiencies in its review processes for clinical investigations. The IRB failed to ensure adequate board composition, properly assess risks to subjects, include all necessary information in informed consent forms, and comply with safeguards for pediatric studies. Additionally, the firm's meeting minutes were insufficient, and it failed to follow procedures for reporting study suspensions.

## Related Officers

- [investigator](https://www.keypedia.com/people/denise-m-visco/14fa6a3e-8d0c-4098-ae13-3575c0332394)
- [investigator](https://www.keypedia.com/people/janet-donnelly/372a47de-fbc1-4ad9-953d-fefc938f4f42)
- [issuing_officer](https://www.keypedia.com/people/dawn-l-wydner/9b193de9-4210-49f1-afe3-0ff308f6c49c)

Company: https://www.keypedia.com/companies/essex-institutional-review-board-inc/7cb55d93-20ab-4c32-a3a4-5628657883eb

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