Houston Fertility Center – FDA 483, Dec 30, 2025

This FDA Form 483 report details significant deficiencies at Houston Fertility Center related to the processing and handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly screen donors for communicable diseases, maintain adequate records, and ensure appropriate labeling for HCT/Ps, including those from ineligible donors. These issues indicate a lack of robust procedures and adherence to regulations concerning donor eligibility and product safety.