FDA 483 - Reproductive Sciences Medical Center, Inc. - April 08, 2026
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An FDA inspection of Reproductive Sciences Medical Center, Inc. in San Diego, CA, a human reproductive tissue establishment, revealed a significant deficiency in donor screening practices. The firm failed to adequately screen anonymous oocyte donors for risk factors of communicable diseases, specifically by not ensuring complete responses on donor history questionnaires. This indicates a potential risk to the safety of oocytes and embryos recovered from these donors.
ID · 3cbecf68-414b-4fd6-8b3c-a9720fa78570