Florida Fertility Institute, P.A. – FDA Warning Letter, Sep 6, 2013

On December 12, 2013, the FDA issued a Warning Letter to Florida Fertility Institute, P.A., following an inspection from August 30 to September 6, 2013. 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 donor specimens for communicable diseases:** Specific instances cited for Hepatitis B, HIV-1, HCV NAT, HIV-1/2, Hepatitis B virus, Hepatitis C virus, and Treponema pallidum. 2. **Inadequate testing for genitourinary tract agents:** Donors were not tested for Chlamydia trachomatis and Neisseria gonorrhea. 3. **Failure to test for cell-associated diseases:** Donors of leukocyte-rich cells were not tested for CMV and HTLV-I/II. 4. **Failure to determine donor ineligibility:** A donor with a positive Chlamydia trachomatis test was deemed eligible, and oocytes were recovered. 5. **Improper timing of donor specimen collection:** Specimens were collected outside the permissible timeframe relative to HCT/P recovery. 6. **Inadequate donor screening:** Lack of current medical history interviews and physical examinations (beyond six months) and an incomplete donor screening questionnaire. 7. **Failure to document donor eligibility