# FDA 483 - Alameda Health System IRB - October 10, 2019

Source: https://www.keypedia.com/records/483/alameda-health-system-irb/c1c9bb25-e6a8-48a4-93a2-b7230bf0b1be

> FDA 483 for Alameda Health System IRB on October 10, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alameda Health System IRB
- Inspection Date: 2019-10-10
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Alameda Health System IRB in Oakland, CA, identified a significant issue regarding conflict of interest. The IRB allowed a member with a conflicting interest to participate in the review of a project, and meeting minutes lacked clarity on the handling of abstentions related to conflicts. This indicates a lapse in ensuring unbiased review processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/humberto-z-gomez/6de682f6-ae2a-45ff-92ab-ba6ac7bb97b4)

Company: https://www.keypedia.com/companies/alameda-health-system-irb/e706dba7-b371-4293-8102-4d89c7e606f9

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