Warning letterPosted June 2, 2026
FDA warning letter to Blue Horizon International, LLC
Unapproved New Drugs/Unlicensed Biological Product Violations
FDA posted a warning letter to Blue Horizon International, LLC on June 2, 2026; the letter is dated May 26, 2026. Subject: Unapproved New Drugs/Unlicensed Biological Product Violations. Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- Blue Horizon International, LLC
- Subject
- Unapproved New Drugs/Unlicensed Biological Product Violations
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2026-05-26
- Posted by FDA
- 2026-06-02
- Source
- FDA warning letters ↗
CFR cited
The record cites 5 sections of 21 CFR Parts 201, 312 and 1271.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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