# FDA 483 - Cooper Health System IRB - December 04, 2025

Source: https://www.keypedia.com/records/483/cooper-health-system-irb/8541abad-76b1-4ac7-b534-21c040bff32a

> FDA 483 for Cooper Health System IRB on December 04, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cooper Health System IRB
- Inspection Date: 2025-12-04
- Product Type: other
- Office Name: New Jersey District Office
- Summary: The FDA inspected Cooper Health System IRB in Camden, NJ, and issued a Form 483 with four observations. The observations primarily concern the lack of adequate written procedures for various critical IRB functions, including project review frequency, reporting findings, initial research review, and reporting noncompliance. This indicates significant procedural deficiencies in the IRB's operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/gabrielle-j-swain/55f33430-41dc-4fae-bac0-ec6ea340feb6)

Company: https://www.keypedia.com/companies/cooper-health-system-irb/f8eba0ee-c0c6-4211-913a-59b20db2f951

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