FDA 483 - Ohio Fertility Providers LLC - May 15, 2025

An FDA inspection of Ohio Fertility Providers LLC in Cincinnati, OH, a human reproductive tissue facility, revealed two significant observations. The firm failed to quarantine HCT/Ps until donor-eligibility determinations were complete, resulting in the transfer of oocytes from a donor with an incomplete history. Additionally, HCT/Ps from donors with incomplete eligibility requirements were not prominently labeled with appropriate warning statements regarding communicable disease risk.