Warning Letter — Blue Horizon International, LLC
The FDA issued a warning letter to Blue Horizon International, LLC following an investigation by the Center for Biologics Evaluation and Research (CBER).
Blue Horizon International, LLC and professionals involved in the manufacturing, marketing, and clinical application of cellular and regenerative medicine products.
The involvement of CBER indicates that the FDA likely identified issues regarding the regulatory classification of the company's products, potentially treating them as unapproved biologics rather than human cells, tissues, or cellular and tissue-based products (HCT/Ps). This signifies continued agency scrutiny on the regenerative medicine sector and the enforcement of premarket authorization requirements for products that do not meet specific exemptions.
Review the regulatory status of any stem cell or regenerative medicine products to ensure they meet the criteria for Section 361 HCT/Ps or have an approved BLA/IND. Verify that all marketing claims align with authorized indications and do not inadvertently classify a tissue product as a drug or biologic.
FDA Warning Letter issued to: Blue Horizon International, LLC. 05/26/2026 — Center for Biologics Evaluation and Research (CBER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-horizon-international-llc-728085-05262026
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