# FDA 483 - Kaiser Foundation Research Institute IRB #8 - September 10, 2024

Source: https://www.keypedia.com/records/483/kaiser-foundation-research-institute-irb-8/422afc63-2f8a-4268-a5f4-ec2bd0a10d45

> FDA 483 for Kaiser Foundation Research Institute IRB #8 on September 10, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kaiser Foundation Research Institute IRB #8
- Inspection Date: 2024-09-10
- Product Type: other
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Kaiser Foundation Research Institute IRB #1 in Oakland, CA, revealed significant deficiencies in its oversight of human subject research. The Institutional Review Board (IRB) failed to adequately conduct continuing review, follow up on suspended research, and ensure ongoing compliance for the MITIGATE study. Furthermore, the institution lacks a comprehensive Human Research Protection Program, compromising its ability to protect human subjects.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)
- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)
- [Supervisory Consumer Safety Officer](https://www.keypedia.com/people/joan-t-briones/f3b6554f-1a5c-4266-8a94-6c7488281659)

Company: https://www.keypedia.com/companies/kaiser-foundation-research-institute-irb-8/e762af6c-6c21-431b-a4c3-7886a2dc0c84

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df