# FDA 483 - Deborah Heart & Lung Center IRB - July 26, 2021

Source: https://www.keypedia.com/records/483/deborah-heart-lung-center-irb/5444d83a-5710-4f83-9928-0f34a09ee4ba

> FDA 483 for Deborah Heart & Lung Center IRB on July 26, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Deborah Heart & Lung Center IRB
- Inspection Date: 2021-07-26
- Product Type: other
- Office Name: New Jersey District Office
- Summary: The FDA inspected Deborah Heart & Lung Center IRB in Browns Mills, NJ, and identified several significant issues. The IRB failed to ensure proper quorum for research reviews and allowed unauthorized individuals to vote during meetings. Additionally, the facility did not follow its written procedures for reporting noncompliance and maintained inadequate meeting minutes, indicating systemic deficiencies in its oversight processes.

## Related Documents

- [483 - 2021-07-26](https://www.keypedia.com/records/483/deborah-heart-lung-center-irb/07072239-3645-46af-b99e-6e7bd8dbf82a)

## Related Officers

- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/deborah-heart-lung-center-irb/901fdeb9-2f37-4c03-8954-e8d736dce7c0

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