Beta Bionics, the company behind the iLet bionic pancreas system, disclosed that it received a formal warning letter from the U.S. Food and Drug Administration (FDA) on January 29, 2026, following an inspection of its Irvine, California facility last June.
According to a securities filing, the FDA cited non conformities related to the company’s quality management system, medical device reporting, and its handling of corrections and removals. Beta Bionics said the warning letter is not expected to impact its ability to manufacture, market, or distribute its current products, including the iLet system.
The company noted that it has already begun addressing the issues raised and is preparing a written response to the FDA, adding that it does not anticipate any disruption to product supply or operations. Beta Bionics said the letter will not affect development of its tubeless insulin pump, Mint, which remains on track for a potential launch by the end of 2027.
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