483
Louisville Reproductive CenterFDA 483 - Louisville Reproductive Center - April 28, 2025
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The FDA inspected Louisville Reproductive Center, a human tissue establishment, from April 23-28, 2025. The inspection revealed significant deficiencies in donor eligibility determination, specifically regarding the testing of semen donors for relevant communicable disease agents and the quarantine of HCT/Ps. These issues indicate a failure to ensure the safety and eligibility of donor tissues.
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ID · 29567dc0-8b65-4a0a-afd3-79a86c012fe4