FDA 483 - Dallas IVF - March 28, 2024

Dallas IVF, a reproductive facility, was cited for failing to adequately screen HCT/P donors and determining them eligible for donation without complete medical record reviews. Specifically, the firm did not perform required physical examinations for several semen and oocyte donors and had incomplete Zika Virus screening for an anonymous oocyte donor. These deficiencies indicate a failure to ensure donor eligibility based on proper screening and testing results.