FDA 483 - Family Fertility Center - September 14, 2021

The FDA inspected Family Fertility Center, a human tissue reproductive establishment, and identified significant deficiencies in donor screening and testing practices. The firm failed to screen oocyte donors for Chlamydia trachomatis and did not test donors for relevant communicable disease agents, such as West Nile Virus. Additionally, donor eligibility determinations were made without complete screening and testing results, raising concerns about the safety of reproductive tissues.