Beta Bionics receives FDA Warning Letter after June 2025 inspection; cites quality system deficiencies

Beta Bionics, Inc.

FDA Warning Letter follows June 2025 inspection of Irvine facility; cites non-conformities in Quality Management System, Medical Device Reporting, and Corrections/Removals.
Warning Letter does not restrict production, marketing, manufacturing, or distribution, nor ability to seek FDA 510(k) clearance.
Company preparing written response; corrective actions already underway; no assurance FDA will be satisfied with outcome.
Company reiterates Mint commercialization guidance for end of 2027 is not materially impacted by Warning Letter.

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