FDA Issues Warning Letter to Beta Bionics Over Quality System Deficiencies
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Beta Bionics Inc. received a warning letter from the FDA due to deficiencies in its Quality Management System following a June 2025 inspection. While the letter does not restrict the company's operations, it must address the cited issues to avoid further action. Beta Bionics has begun corrective measures and is preparing a response, but resolution timing is uncertain. The company does not anticipate the warning letter to significantly affect its planned commercialization of Mint by the end of 2027.
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