# FDA 483 - AtlantiCare Regional Medical Center IRB - February 10, 2023

Source: https://www.keypedia.com/records/483/atlanticare-regional-medical-center-irb/cde8cd30-ff26-4d9f-b8c3-a38181682eb7

> FDA 483 for AtlantiCare Regional Medical Center IRB on February 10, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AtlantiCare Regional Medical Center IRB
- Inspection Date: 2023-02-10
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AtlanticCare Regional Medical Center IRB in Atlantic City, NJ, revealed significant deficiencies in its Institutional Review Board operations. Observations included an IRB member participating in a review with a conflict of interest, the inappropriate use of expedited review for research involving greater than minimal risk, and a failure to prepare complete records for continuing review activities. These findings indicate a need for improved adherence to regulatory requirements and internal procedures for human subject protection.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/atlanticare-regional-medical-center-irb/e064a506-03d2-4568-ae89-83d8a17d2bce

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