# FDA WARNING_LETTER - Center for Fertility and Gynecology - June 24, 2008

Source: https://www.keypedia.com/records/warning_letter/center-for-fertility-and-gynecology/fe2973fa-8228-43a5-ac8a-ce972c681af7

> FDA WARNING_LETTER for Center for Fertility and Gynecology on June 24, 2008. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Center for Fertility and Gynecology
- Inspection Date: 2008-06-24
- Product Type: Biologics
- Office Name: Los Angeles District Office
- Summary: The FDA conducted an inspection of The Center for Fertility and Gynecology from June 17-24, 2008, identifying significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include:
1.  **Failure to use FDA-licensed/approved donor screening tests:** Three semen donors were tested by a laboratory not using FDA-approved tests, impacting embryos transferred or cryopreserved.
2.  **Failure to test for relevant communicable diseases:** Two semen donors were not tested for HTLV-I/II and/or CMV.
3.  **Failure to test for genitourinary tract agents:** Three donors (semen and oocyte) were not tested for Chlamydia trachomatis and Neisseria gonorrhea when HCT/Ps were not recovered by contamination-free methods.
4.  **Failure to collect donor specimens within required timeframe:** Specimens for two semen donors were collected outside the 7-day window relative to donation.
5.  **Failure to screen donors via medical records:** Records for three semen and three oocyte donors lacked documentation of a donor medical history interview and physical examination, essential for assessing communicable disease risk factors.
6.  **Failure to document donor eligibility:** No documentation was found for seven donor records to substantiate a responsible person determined donor eligibility prior to donation.
7.

## Related Officers

- [Mariza Jafary](https://www.keypedia.com/people/mariza-jafary/307fe792-b470-40dd-b29a-40d8b631bf4e)
- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [John Larry Stevens](https://www.keypedia.com/people/john-larry-stevens/89eeaf60-bbbf-4ad3-b252-54d39b60baf6)
- [Jeff Farrar](https://www.keypedia.com/people/jeff-farrar/ceeae1b7-384d-4aa3-af23-071c8261cccf)

Company: https://www.keypedia.com/companies/center-for-fertility-and-gynecology/2fb0e503-d698-4d11-b4b9-0e892f8ad018

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b