FDA WARNING_LETTER - Advanced Fertility Group, PC - April 13, 2011

The FDA conducted an inspection of Advanced Fertility Group, PC from March 28, 2011, to April 13, 2011, documenting significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. Failure to test specimens from anonymous or directed reproductive donors for relevant communicable disease agents (e.g., HIV-1/2, HBV, HCV, *Treponema pallidum*) as per 21 CFR 1271.85(a). 2. Failure to collect donor specimens for testing within the required timeframe (up to 7 days before or after recovery) as per 21 CFR 1271.80(b). 3. Failure to test viable, leukocyte-rich cells for HTLV-I/II and/or CMV to reduce transmission risk (21 CFR 1271.85(b)). 4. Failure to test for genitourinary tract communicable disease agents (e.g., *Chlamydia trachomatis*, *Neisseria gonorrhea*) when HCT/Ps were not recovered by methods ensuring freedom from contamination (21 CFR 1271.85(c)). 5. Failure to determine donor eligibility based on complete screening and testing results *before