FDA WARNING_LETTER - Louisville Reproductive Center - April 28, 2025

The FDA issued a Warning Letter to Louisville Reproductive Center on January 23, 2026, following an inspection from April 23 to April 28, 2025. The inspection revealed significant violations of regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271. Key issues included the failure to adequately test reproductive donor specimens for relevant communicable disease agents, such as HIV-1, HCV, HBV, WNV, and HTLV-I/II. Additionally, the center failed to properly screen donors by reviewing medical records, with the donor questionnaire lacking crucial questions to assess communicable disease risks. A third major violation was the failure to establish and maintain comprehensive procedures for donor testing, screening, and eligibility determination.

The FDA expressed serious concerns, noting similar violations were cited in 2021, indicating prior corrective actions were ineffective. The company is required to promptly correct all violations and implement measures to prevent recurrence. All HCT/Ps (oocytes, semen, embryos) from donors with incomplete eligibility determinations must be quarantined. Any future use or transport of quarantined HCT/Ps necessitates a prior approved exemption or alternative from the FDA. A written response detailing specific corrective actions, prevention plans, and documentation is required within fifteen working days.