# FDA WARNING_LETTER - Family Fertility Center - June 26, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/family-fertility-center/fe84dd1c-513c-4524-8e98-213e21078dee

> FDA WARNING_LETTER for Family Fertility Center on June 26, 2019. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Family Fertility Center
- Inspection Date: 2019-06-26
- Product Type: Biologics
- Office Name: Division of Biological Products Operations II
- Summary: 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

## Related Documents

- [483 - 2019-06-26](https://www.globalkeysolutions.net/records/483/family-fertility-center/1724437c-2ce6-413a-91f7-521934680f8d)
- [483 - 2020-03-16](https://www.globalkeysolutions.net/records/483/family-fertility-center/27a2a52b-986c-49f7-88e6-fe58c929a929)
- [483 - 2024-01-30](https://www.globalkeysolutions.net/records/483/family-fertility-center/4ceb5727-1686-4ee5-aa8f-498b57d8b9b6)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/family-fertility-center/b744bbbf-0b40-4500-9bbb-77ee1c9b29f9

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