FDA 483 - Kofinas Fertility Group - April 09, 2025

An FDA inspection of Kofinas Fertility Group in New York revealed significant deficiencies in their handling of reproductive human tissues. The firm failed to properly determine donor eligibility based on complete screening and testing, leading to potential communicable disease risks. Additionally, issues were identified with inadequate labeling of HCT/Ps and inaccurate or incomplete donor eligibility records.