FDA 483 - Generation Next Fertility - January 12, 2024

Generation Next Fertility in New York, NY, was cited for significant deficiencies in its human reproductive tissue operations. The inspection revealed that procedures for determining donor eligibility were inadequate, particularly concerning Zika Virus screening criteria. Additionally, the firm failed to properly screen oocyte donors for communicable disease risks, and donor eligibility records were found to be inaccurate, lacking clear final determination.