483
Columbia University Fertility CenterColumbia University Fertility Center – FDA 483, Dec 20, 2024
Record Details
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.
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