FDA 483 - American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. - June 09, 2022

An FDA inspection of American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. in Irvine, CA, revealed a significant issue regarding the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to prominently label HCT/Ps from ineligible donors with a Biohazard legend and a warning statement about reactive test results, specifically for embryos derived from an HBc positive donor. This indicates a serious lapse in donor eligibility and product labeling procedures.