Beta Bionics Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) following an inspection of its Irvine, California facility in June 2025. The FDA cited deficiencies in the company's Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated through a Form 483. While the warning letter does not currently restrict Beta Bionics' ability to produce, market, or seek FDA clearance for new products, the company must address the cited non-conformities to the FDA’s satisfaction to avoid potential further legal or regulatory action. Beta Bionics has initiated corrective actions and is preparing a written response, but cannot guarantee when the issues will be resolved. The company does not expect the warning letter to materially impact its planned commercialization of Mint by the end of 2027.

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