FDA WARNING_LETTER - Jarrett Fertility Group, LLC - April 11, 2008

The FDA conducted inspections of Jarrett Fertility Group, LLC and its related entities (Heartland Andrology and Laboratory Services LLC, Heartland Reproductive Biology LLC) in Carmel, Indiana, from March 7 to April 11, 2008. The inspections revealed multiple deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in 21 CFR Part 1271, issued under Section 361 of the Public Health Service Act.

Key violations included: 1. **Failure to test for relevant communicable disease agents (21 CFR 1271.85(a))**: Specific instances cited include not testing donors for HIV-2, HIV-1, and Hepatitis C virus (by NAT method). 2. **Failure to test for HTLV-I/II and CMV (21 CFR 1271.85(b))**: Several semen donors were not tested for HTLV-I/II and/or CMV. 3. **Failure to test for genitourinary tract agents (21 CFR 1271.85(c))**: Donors were not tested for *Chlamydia trachomatis* and/or *Neisseria gonorrhea* in cases where HCT/Ps were not recovered by methods ensuring freedom from contamination. 4. **Failure to collect donor specimens within required timeframes