IVF Phoenix – FDA Warning Letter, Feb 5, 2010

The FDA inspected IVF Phoenix from February 1-5, 2010, identifying significant deviations from 21 CFR Part 1271 regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations included: 1. **Failure to determine ineligible donors:** A semen donor (b)(6) with reactive anti-HBc was deemed eligible, and his HCT/Ps were used, violating 21 CFR 1271.80(d)(1). The HCT/Ps were also not labeled per 21 CFR 1271.65(b)(2). An anonymous oocyte donor (b)(6) tested positive for Chlamydia trachomatis, but her oocytes were used. 2. **Failure to follow established donor eligibility procedures:** For anonymous oocyte donor (b)(6), the "Donor Summary of Records" form lacked eligibility documentation, and a "don't know" answer on the screening questionnaire was not further investigated, contrary to SOP #01, violating 21 CFR 1271.47(a).

While IVF Phoenix's February 22, 2010, response regarding updated procedures and labeling for HCT/Ps from ineligible donors was "generally adequate," concerns remain about documenting departures from procedures and regulatory requirements. The FDA clarified that departures must be consistent with 2