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

Elite IVF & Fertility Solutions LLC in Odessa, TX, a reproductive establishment, was cited for two observations related to deficiencies in their record-keeping practices for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed issues with incomplete donor eligibility records, including missing establishment addresses and illegible information, which were also noted in a previous inspection.