FDA 483 - Fertility and Advanced Reproductive Medicine at UTSW - December 13, 2023

An FDA inspection of Fertility and Advanced Reproductive Medicine at UTSW in Dallas, TX, revealed significant issues with donor eligibility and HCT/P handling. The firm failed to ensure donor testing was negative for communicable disease agents, maintain proper documentation of donor eligibility, and adequately screen donors for disease risk factors. Additionally, HCT/Ps not requiring eligibility determination lacked appropriate warning labels.