FDA 483 - Conceive Fertility Center - June 13, 2025

The inspection of Conceive Fertility Center in Dallas, TX, revealed significant deficiencies in donor eligibility determination and documentation for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included failures to properly state donor eligibility, ensure qualified personnel performed determinations, establish procedures for CMV reactive donors, and maintain comprehensive donor eligibility procedures, along with issues regarding non-English donor information. These issues indicate a lack of robust controls over critical aspects of HCT/P donor screening and eligibility.