Issued to Louisville Reproductive Center. Serious post-market compliance violation.
Issued
January 23, 2026Product
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Company
Louisville Reproductive Center
Review center
CBERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Louisville Reproductive Center concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on January 23, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.