483
KUPI Reproductive Endocrinology & Infertility LabFDA 483 - KUPI Reproductive Endocrinology & Infertility Lab - March 06, 2023
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Record Details
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.
- Inspection Date
- March 6, 2023
- Product Type
- Biologics
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