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Louisville Reproductive Center, a biologics facility specializing in human cells and tissues for reproductive use, failed to conduct required infectious disease testing on directed semen donors in violation of 21 CFR 1271.85. Specifically, the facility did not test donors for critical communicable disease agents including HIV-1, hepatitis B and C, West Nile Virus, and HTLV-I/II before determining donors eligible and releasing their specimens for use. These violations were identified during an FDA inspection conducted in April 2025 at the facility's Louisville, Kentucky location.