# FDA 483 - ORM Fertility LLC - April 06, 2022

Source: https://www.globalkeysolutions.net/records/483/orm-fertility-llc/9a5e21ed-0d10-4d0d-b3e8-8a79a2970a4c

> FDA 483 for ORM Fertility LLC on April 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ORM Fertility LLC
- Inspection Date: 2022-04-06
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of ORM Fertility LLC, a human reproductive tissue establishment in Bellevue, WA, revealed two significant observations. The firm failed to determine HCT/P donor eligibility based on screening and testing, specifically creating HCT/Ps from donor oocytes without a physical exam or prior eligibility determination. Additionally, the firm's records for HCT/Ps included the donor's name, indicating a failure to use a unique donor identifier to protect personal information.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [investigator](https://www.globalkeysolutions.net/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)

Company: https://www.globalkeysolutions.net/companies/orm-fertility-llc/d02a7667-654d-44d4-82f4-1dc6dd5ce4a6

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