Beta Bionics Receives Warning Letter from FDA

In a regulatory 8-K filing on Friday, the company stated: "On January 29, 2026, Beta Bionics received a warning letter from the U.S. Food and Drug Administration following inspection of the Company's facility in Irvine, California that occurred from June 9, 2025 through June 26, 2025. In the Warning Letter, the FDA cited deficiencies in the response letters sent by the Company to the FDA following the FDA's issuance of a Form 483, List of Investigational Observations, which was issued to the Company by the FDA in connection with the aforementioned inspection that took place in June 2025. The Warning Letter highlights non-conformities observed by the FDA in relation to the Company's Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483. The Warning Letter does not restrict the Company's ability to produce, market, manufacture or distribute products, nor restrict the Company's ability to seek FDA 510(k) clearance of new products. The Company takes the observations described in the Warning Letter seriously, and is currently preparing a written response to the Warning Letter. Several corrective actions have already occurred including improvements to the processes identified in the warning letter."