Center for Fertility and Gynecology – FDA Warning Letter, Jun 24, 2008

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.