FDA 483 - KUPI Reproductive Endocrinology & Infertility Lab - March 06, 2023

KUPI Reproductive Endocrinology & Infertility Lab in Overland Park, KS, was cited for failing to adequately screen donors of reproductive Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps). Specifically, the firm did not screen donors for risks associated with Zika Virus, a relevant communicable disease agent, prior to transferring HCT/Ps to gestational carriers. This lapse in screening poses a potential public health risk.