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

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