FDA 483 - SpringCreek Fertility - January 05, 2023

SpringCreek Fertility in Centerville, OH, a reproductive tissue establishment, was cited for failing to quarantine HCT/Ps until donor-eligibility determinations were complete. This serious issue involved multiple anonymous oocyte and directed sperm donors whose tissues were distributed despite incomplete screening for communicable diseases and lack of proper medical record review. The report highlights significant deficiencies in donor screening and eligibility processes, potentially impacting recipient safety.