FDA 483 - Green Valley Fertility Partners - May 14, 2025

An FDA inspection of Green Valley Fertility Partners in Henderson, NV, revealed that the firm failed to adequately screen donors for communicable disease risk factors. This deficiency stemmed from an insufficient donor history questionnaire, which led to the use and storage of reproductive tissues from potentially affected donors. The firm transferred fertilized oocytes from these donors into recipients and currently stores remaining oocytes and semen vials.