Oregon Fertility Institute, LLCAugust 18, 2021

FDA 483 - Oregon Fertility Institute, LLC - August 18, 2021

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Record Details

An FDA inspection of Oregon Fertility Institute, LLC in Portland, OR, identified a deficiency in their donor screening process. The firm's questionnaire for egg donors regarding relevant communicable diseases, specifically Zika virus, did not provide adequate information on relevant risk areas. This indicates a concern with ensuring the eligibility of HCT/P donors.

Company: Oregon Fertility Institute, LLC
Inspection Date: August 18, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West VI
Person: Paul M. Chefor (Investigator)

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