FDA 483 - Fort Worth Fertility P.A. - April 24, 2025

Fort Worth Fertility P.A. in Fort Worth, TX, was inspected regarding its reproductive HCT/P operations. The inspection revealed significant deficiencies in donor screening processes, donor eligibility determinations, record-keeping for communicable disease testing, and labeling of HCT/Ps. These issues indicate a failure to ensure the safety and proper handling of donated reproductive tissues.