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

Source: https://www.globalkeysolutions.net/records/483/oregon-fertility-institute-llc/012b1d86-6d9f-4557-990b-828f9119af67

> FDA 483 for Oregon Fertility Institute, LLC on August 18, 2021. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Oregon Fertility Institute, LLC
- Inspection Date: 2021-08-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/paul-m-chefor/96bea4a8-b1ee-4870-ae8b-24794c67da21)

Company: https://www.globalkeysolutions.net/companies/oregon-fertility-institute-llc/c9882bdd-0be4-4a5e-8b99-daacc414007b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822