# FDA WARNING_LETTER - American Fertility Medical Center, Genetic Infertility & Andrology Lab - January 22, 2020

Source: https://www.keypedia.com/records/warning_letter/american-fertility-medical-center-genetic-infertility-andrology-lab/71b15c2b-d73d-475a-867a-749af1b02973

> FDA WARNING_LETTER for American Fertility Medical Center, Genetic Infertility & Andrology Lab on January 22, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: American Fertility Medical Center, Genetic Infertility & Andrology Lab
- Inspection Date: 2020-01-22
- Product Type: Biologics
- Office Name: Division of Biological Products Operations II
- Summary: On April 2, 2020, the FDA issued a Warning Letter to American Fertility Medical Center, Genetic Infertility & Andrology Lab, following an inspection from January 14-22, 2020. The inspection revealed significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include:
1. **Failure to test specimens for communicable diseases:** Donor records for multiple oocyte and semen donors lacked required testing results for HIV-1/2, hepatitis B/C, syphilis, gonorrhea, and chlamydia.
2. **Failure to determine ineligible donors:** Donors with reactive screening tests for syphilis or hepatitis B core antigen were not deemed ineligible.
3. **Inadequate donor screening:** Seven donor records lacked documentation of medical history interviews or physical examinations to screen for communicable disease risks.
4. **Lack of documented donor eligibility determinations:** Donor records did not include forms documenting eligibility determinations, responsible person's signature, or date.
5. **Absence of CMV release procedures:** No standard operating procedure existed for communicating CMV test results to physicians for informed decision-making.
6. **Failure to establish and maintain procedures:** The firm lacked comprehensive procedures for donor testing, screening, and eligibility determination.

The FDA noted that no response to the initial FDA-483 observations had been received. Additional

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- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/american-fertility-medical-center-genetic-infertility-andrology-lab/2846d449-e3d9-4351-a49b-5ff295dd0c71

Office: https://www.keypedia.com/offices/division-of-biological-products-operations-ii/a2187202-a132-4872-9ff9-2b97ae88ed9f