FDA 483 - Nest Cryobank LLC - September 17, 2024

Nest Cryobank LLC in San Francisco, CA, was inspected from September 16-17, 2024, and received one observation. The firm failed to determine donors ineligible who had risk factors for communicable disease agents. Specifically, an oocyte donor with a recent Zika virus travel history was deemed eligible, and her oocytes were used to create cryopreserved embryos awaiting implantation.