Family Fertility Center – FDA Warning Letter, Jun 26, 2019

On September 30, 2019, the FDA issued a Warning Letter to Family Fertility Center following an inspection from June 18-26, 2019. The inspection revealed significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to screen donors for communicable diseases:** Six directed or anonymous oocyte donors lacked evidence of communicable disease risk factor assessment. The firm failed to screen donors for Zika virus (ZIKV) risk factors, including medical diagnosis, residence/travel to ZIKV areas, or sexual contact with an infected person within six months. 2. **Failure to document donor eligibility:** The responsible person did not determine and document eligibility for two anonymous oocyte donors based on health risk assessments, physical examinations, and testing results. 3. **Failure to determine ineligible donors:** An anonymous oocyte donor who traveled to a ZIKV transmission risk area was incorrectly determined eligible. 4. **Failure to establish and maintain adequate procedures:** * No written procedure for ZIKV screening and evaluation of donors with ZIKV risk factors. * Donor eligibility documentation was not consistently followed for at least nine anonymous oocyte donors. * Procedures for Reproductive Donor Communicable Disease Testing did not include Hepatitis B virus (HBV) NAT and West Nile