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Blue Horizon International, LLC Warning Letter Details

Warning Letter

Blue Horizon International, LLC

Recipient Title Chief Medical Officer and Founder, Blue Horizon International, LLC, 214 State Street Suite 101 Hackensack , NJ 07601 United States

Issue DateMay 26, 2026

FEI NumberN/A

Violations6

CountryUnited States

Issuing Office

Center for Biologics Evaluation and Research (CBER)

Product Type

Biologics

Status

Open

Subject

Unapproved New Drugs/Unlicensed Biological Product Violations

Blue Horizon International, LLC FDA Warning Letter, May 26, 2026