FDA 483 - Billings Clinic Innovative Fertility - July 14, 2023

An FDA inspection of Billings Clinic Innovative Fertility identified a critical lapse in donor screening procedures. The firm failed to adequately screen reproductive tissue donors for communicable disease agents and diseases, including a specific instance where Zika Virus screening was omitted and another where no donor risk assessment was performed. This indicates a significant concern regarding the safety and eligibility of reproductive tissue donors.