# FDA 483 - National Institutes of Health IRB - October 11, 2023

Source: https://www.globalkeysolutions.net/records/483/national-institutes-of-health-irb/d70ab36d-7d76-4749-8fbf-400212346bfa

> FDA 483 for National Institutes of Health IRB on October 11, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Institutes of Health IRB
- Inspection Date: 2023-10-11
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of the National Institutes of Health IRB in Bethesda, MD, revealed that for non-expedited reviews, research approved by the IRB did not consistently receive the required majority approval from members present. This was specifically due to a lack of quorum during several meetings between July and September 2023, where an insufficient number of primary members voted on FDA-regulated studies.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)
- [investigator](https://www.globalkeysolutions.net/people/brittany-l-carpenter/600db4d0-0b6b-435f-b511-2ca10f292d5d)

Company: https://www.globalkeysolutions.net/companies/national-institutes-of-health-irb/60ed3db6-f6bf-406d-b90f-b4be0204ecaf

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64