FDA 483 - Elite IVF & Fertility Solutions LLC - July 13, 2023

Elite IVF & Fertility Solutions LLC in Odessa, TX, received a Form FDA 483 with three observations related to donor screening and record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm was cited for inadequate screening for communicable disease risk factors, failure to determine donor eligibility, and incomplete summaries of communicable disease test results. One observation regarding donor eligibility was removed after discussion with management.