Dive Brief:
- Beta Bionics has received a warning letter from the Food and Drug Administration following an inspection last year, the company disclosed on Friday.
- The diabetes technology company said in a securities filing that the warning letter concerns non-conformities with the company’s quality management system, medical device reporting, and correction and removals. The warning letter has not yet been posted by the FDA.
- Beta Bionics does not expect the warning letter to affect its ability to “produce, market, manufacture or distribute products.” The company did not immediately respond to a request for comment.
Dive Insight:
The FDA uses warning letters to bring companies into compliance after identifying significant violations.
Beta Bionics received the warning letter on Jan. 29. It follows a Form 483 that the company received last year after an inspection of its facility in Irvine, California, between June 9 and June 26.
The company said in the filing that it has already taken actions to improve the processes described in the warning letter, and it is working on a written response to the FDA.
The firm does not expect the warning letter to affect the planned launch of a new insulin patch pump by the end of 2027. Beta Bionics unveiled a prototype of the device, called Mint, last year at the American Diabetes Association’s Scientific Sessions. The company also does not expect the warning letter to affect its financial results.
Beta Bionics shared preliminary earnings results last month, with expected net sales of at least $32 million in the fourth quarter, a 56% increase year over year.
Leerink Partners analyst Mike Kratky described the warning letter as a “particularly unwelcome development,” in a note to clients on Friday. Kratky said Beta Bionics’ management expressed confidence in the company’s ability to avoid disruption from the warning letter and plans to deliver products as usual.
