FDA 483 - CNY Fertility Center, PLLC - December 10, 2019

CNY Fertility Center in Syracuse, NY, a human reproductive tissue establishment, was cited for deficiencies related to donor testing and screening. The firm failed to test oocyte and semen donors for West Nile Virus (WNV) NAT and did not include WNV NAT results in donor eligibility forms. These issues indicate a failure to ensure donors were properly screened for communicable disease agents.