Alameda Health System IRBOctober 10, 2019

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

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Record Details

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.

Company: Alameda Health System IRB
Inspection Date: October 10, 2019
Product Type: Other
Office: Division of Human and Animal Food Operations - West V
Person: Humberto Z. Gomez (investigator)

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ID · c1c9bb25-e6a8-48a4-93a2-b7230bf0b1be