American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.June 9, 2022

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

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Record Details

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.

Company: American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.
Inspection Date: June 9, 2022
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
Person: Yvonne C. Wilkes (investigator)

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ID · 48169198-c812-4df2-9cea-905473b95674