FDA 483 - Conceive Fertility Center - June 13, 2025
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Conceive Fertility Center in Dallas, TX, was cited for multiple deficiencies related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) donor eligibility and record-keeping. Observations included failures to properly document donor eligibility, ensure determinations were made by qualified personnel, establish procedures for CMV-reactive donors, and maintain donor information in English with authenticated translations. These issues indicate significant gaps in their quality system for HCT/P donor management.
ID · 732b65a9-c000-4d9b-9a13-4be267ce6f08