R3 Medical Companies – FDA Warning Letter, Dec 16, 2025

On August 14, 2026, the FDA issued a warning letter to R3 Medical Companies, specifically targeting its subsidiaries Bello Bio, LLC and Regen Suppliers, LLC, following inspections conducted between November 17 and December 16, 2025. The agency found that the companies were marketing several umbilical cord-derived products, including ReBellaWJ and ReBellaXO, as treatments for serious medical conditions like Parkinson’s disease, diabetes, and heart failure. These products were being distributed without the necessary FDA approvals or biological licenses required under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Beyond the lack of marketing authorization, the FDA identified significant manufacturing violations. These included a failure to validate sterilization and production processes, inadequate cleaning procedures for sterile work environments, and the assignment of expiration dates without supporting stability data. Furthermore, the company failed to implement proper donor screening for certain communicable diseases. The FDA has mandated that R3 Medical Companies submit a written response within 15 working days. This response must detail the specific steps taken to correct these violations, address the status of products already in circulation, and outline a plan to prevent future non-compliance. Failure to take adequate corrective action may result in legal consequences such as product seizures or injunctions.