FDA 483 - ORM Fertility LLC - April 06, 2022

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.