FDA 483 - Louisville Reproductive Center - April 28, 2025

Louisville Reproductive Center, a human tissue establishment, was cited for three observations during an FDA inspection. The primary issues involved failures in testing semen donors for relevant communicable disease agents, including HIV, HBV, HCV, West Nile Virus, HBc, and HTLV 1 and 2. Additionally, the firm failed to quarantine Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) until donor eligibility determinations were completed.