FDA 483 - ORM Fertility LLC - April 06, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 9a5e21ed-0d10-4d0d-b3e8-8a79a2970a4c