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

Source: https://www.keypedia.com/records/483/deborah-heart-lung-center-irb/07072239-3645-46af-b99e-6e7bd8dbf82a

> 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 and issued a Form 483 with four observations related to deficiencies in IRB meeting procedures and documentation. The findings include failures to meet quorum requirements for voting, allowing non-rostered individuals to vote, and not adhering to written procedures for reporting noncompliance. Additionally, meeting minutes lacked sufficient detail regarding voting records and risk level discussions for device studies.

## Related Documents

- [483 - 2021-07-26](https://www.keypedia.com/records/483/deborah-heart-lung-center-irb/5444d83a-5710-4f83-9928-0f34a09ee4ba)

## 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