FDA 483 - ORM Fertility, LLC. - February 14, 2019

An FDA inspection of Oregon Reproductive Medicine, LLC in Portland, Oregon, revealed significant issues with donor eligibility records and specimen collection practices. The firm was cited for inaccurate donor records, including incorrect HBc antibody results and failure to document HBV risk, as well as for collecting donor specimens for communicable disease testing outside the valid timeframes relative to tissue collection.