FDA 483 - Columbia University Fertility Center - December 20, 2024

The FDA inspected Columbia University Fertility Center, a human reproductive tissue establishment in New York, NY, and issued a Form 483 with five observations. Deficiencies included untimely communicable disease testing for donors, improper donor eligibility determinations, and failure to label HCT/Ps from ineligible donors with biohazard warnings. The firm also lacked a standard operating procedure for releasing HCT/Ps from CMV-reactive donors.