FDA 483 - Illume Fertility - May 08, 2026
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Illume Fertility in Norwalk, CT, a reproductive human tissue establishment, was cited for two observations during an FDA inspection. The firm failed to maintain proper records for anonymous oocyte donors, as donor names were found in accompanying documentation. Additionally, the inspection revealed significant deficiencies in the labeling of HCT/Ps, including fertilized oocytes and semen, which lacked required warning statements regarding donor screening, testing status, autologous use, and communicable disease risks.
ID · c80a9ef6-5218-4042-98f2-eaeba8573d2c