FDA 483 - Houston Fertility Center - December 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.