# FDA 483 - Robert Wood Johnson U Hosp @ Hamilton IRB - December 22, 2021

Source: https://www.keypedia.com/records/483/robert-wood-johnson-u-hosp-hamilton-irb/5a58fc23-5a11-45f2-ae33-4f0e87e5ee9b

> FDA 483 for Robert Wood Johnson U Hosp @ Hamilton IRB on December 22, 2021. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Robert Wood Johnson U Hosp @ Hamilton IRB
- Inspection Date: 2021-12-22
- Product Type: other
- Office Name: New Jersey District Office
- Summary: Robert Wood Johnson U Hosp @ Hamilton IRB was cited for significant deficiencies in its Institutional Review Board (IRB) operations. The inspection revealed failures in updating IRB registration, maintaining complete correspondence with investigators, and ensuring detailed meeting minutes. Additionally, the IRB did not retain required research records for the mandated three-year period.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/robert-wood-johnson-u-hosp-hamilton-irb/57b77081-e1aa-4e2c-b3e2-3595d61d7b3c

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