FDA 483 - Positive Steps Fertility, PLLC - August 16, 2022

An FDA inspection of Positive Steps Fertility, PLLC in Madison, MS, revealed significant deficiencies in their donor screening processes for reproductive tissues. The firm failed to adequately screen thirteen anonymous oocyte donors for communicable disease risk factors, specifically Zika virus. Additionally, the firm lacked established procedures for screening HCT/Ps for West Nile and Zika viruses, indicating a failure to ensure donor eligibility and protect recipients from potential disease transmission.