# FDA 483 - Santa Clara Valley Medical Center IRB - June 03, 2021

Source: https://www.keypedia.com/records/483/santa-clara-valley-medical-center-irb/1175d894-c67c-4060-90ea-9d7535555d69

> FDA 483 for Santa Clara Valley Medical Center IRB on June 03, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Santa Clara Valley Medical Center IRB
- Inspection Date: 2021-06-03
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Santa Clara Valley Medical Center IRB in San Jose, CA, revealed two significant issues. The IRB failed to ensure that research, other than expedited reviews, consistently received approval from a majority of members present. Additionally, the facility did not properly maintain a comprehensive list of its IRB members, lacking crucial details for several individuals.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/santa-clara-valley-medical-center-irb/0550f2bb-e176-4532-b6b7-433b14e7a0b8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b