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

Source: https://www.keypedia.com/records/483/american-fertility-medical-center-genetic-infertility-andrology-laboratory-inc/48169198-c812-4df2-9cea-905473b95674

> FDA 483 for American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. on June 09, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.
- Inspection Date: 2022-06-09
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2020-01-22](https://www.keypedia.com/records/483/american-fertility-medical-center-genetic-infertility-andrology-laboratory-inc/db9a37de-744b-425a-816f-10bca14280f2)

## Related Officers

- [investigator](https://www.keypedia.com/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

Company: https://www.keypedia.com/companies/american-fertility-medical-center-genetic-infertility-andrology-laboratory-inc/26838482-772d-4c65-a350-ceac46b0c62e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6