# FDA 483 - Children's National Medical Center IRB - June 06, 2019

Source: https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/c3864a46-56f0-4bd6-b51c-502cb15b2a6c

> FDA 483 for Children's National Medical Center IRB on June 06, 2019. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Children's National Medical Center IRB
- Inspection Date: 2019-06-06
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected Children's National Medical Center IRB and found significant deficiencies in their operations. The IRB failed to promptly report instances of serious non-compliance and study suspensions to the FDA. Additionally, the IRB did not consistently meet quorum requirements for convened meetings and failed to maintain accurate and complete membership rosters.

## Related Documents

- [483 - 2019-06-06](https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/cd660198-2ab9-4959-a546-d2515ce955b9)
- [483 - 2025-05-20](https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/8a612a73-287b-4027-ae47-dff51ceb39a2)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.globalkeysolutions.net/companies/childrens-national-medical-center-irb/b85c818b-4db6-4f98-a73b-5ba95b927999

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e