Blue Horizon International, LLC

Warning LetterOpen

Recipient Title Chief Medical Officer and Founder, Blue Horizon International, LLC, 214 State Street Suite 101 Hackensack , NJ 07601 United StatesIssued May 26, 2026Center for Biologics Evaluation and Research (CBER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateMay 26, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Blue Horizon International, LLC
Location: Recipient Title Chief Medical Officer and Founder, Blue Horizon International, LLC, 214 State Street Suite 101 Hackensack , NJ 07601 United States
FEI Number: N/A
Country: United States
Issue Date: May 26, 2026
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