Issued to Blue Horizon International, LLC. Serious post-market compliance violation.
Issued
May 26, 2026Product
Unapproved New Drugs/Unlicensed Biological Product Violations
Company
Blue Horizon International, LLC
Review center
CBERStage
Final Decision
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FDA issued a warning letter to Blue Horizon International, LLC concerning Unapproved New Drugs/Unlicensed Biological Product Violations. 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 May 26, 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.