FDA 483 - Elite IVF & Fertility Solutions LLC - March 28, 2025

Elite IVF & Fertility Solutions LLC in Odessa, TX, was inspected regarding its reproductive establishment practices. The inspection revealed two observations primarily concerning incomplete and illegible donor eligibility records for HCT/Ps, specifically oocyte donors. Issues included missing establishment addresses on Summary of Records and various omissions and illegibility in donor eligibility determination forms, some of which were recurring discussion items from previous inspections.