# FDA WARNING_LETTER - IVF Phoenix - February 05, 2010

Source: https://www.keypedia.com/records/warning_letter/ivf-phoenix/4ec6bedc-379e-45e1-b5c0-5b559b19387c

> FDA WARNING_LETTER for IVF Phoenix on February 05, 2010. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: IVF Phoenix
- Inspection Date: 2010-02-05
- Product Type: Biologics
- Office Name: Los Angeles District Office
- Summary: 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

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Company: https://www.keypedia.com/companies/ivf-phoenix/9fd00346-6c5d-429f-8853-3f572c77d8b8

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