# FDA Warning Letter: Blue Horizon International, LLC
> 2026-06-02 · Center for Biologics Evaluation and Research (CBER) · `3f645f3914c01213`
## Letter
- **Company:** Blue Horizon International, LLC
- **Posted Date:** 2026-06-02
- **Letter Issue Date:** 2026-05-26
- **Issuing Office:** Center for Biologics Evaluation and Research (CBER)
## Subject
Unapproved New Drugs/Unlicensed Biological Product Violations
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*Source: [FDA Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) · MORVS · CC0 1.0*