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

Source: https://www.keypedia.com/records/warning_letter/jarrett-fertility-group-llc/7313061a-c1eb-495e-8e69-a84872233f51

> FDA WARNING_LETTER for Jarrett Fertility Group, LLC on April 11, 2008. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jarrett Fertility Group, LLC
- Inspection Date: 2008-04-11
- Product Type: Biologics
- Office Name: Detroit District Office
- Summary: 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

## Related Officers

- [Ms.](https://www.keypedia.com/people/joanne-m-givens/7d6d17bd-5f41-4cdf-8f88-488b560f73f8)
- [Sandra Williams](https://www.keypedia.com/people/sandra-williams/c90e1a51-00ee-4e1e-99a5-1808cc83302b)

Company: https://www.keypedia.com/companies/jarrett-fertility-group-llc/cf46f6ec-56a1-433d-987d-6f6dac607ec9

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03