FDA 483 - Denver Fertility Care - May 10, 2024

Denver Fertility Care, a reproductive tissue establishment in Englewood, CO, was cited for deficiencies in donor eligibility determination. The inspection revealed failures in testing donors for relevant communicable disease agents, specifically West Nile Virus, and inadequate screening of donor medical records for diseases like Creutzfeldt-Jakob Disease. These issues indicate a risk to the safety of donor tissues.