FDA 483 - Conceive Fertility Center - October 15, 2021

Conceive Fertility Center in Irving, TX, a reproductive HCT/P establishment, was cited for significant deficiencies in its donor eligibility program. The inspection revealed a lack of established and maintained procedures for testing, screening, and determining HCT/P donor eligibility, affecting 102 donors. Additionally, the firm failed to test oocyte and semen donors for West Nile Virus during the WNV season in 2018.