Beta Bionics receives FDA warning letter [Yahoo! Finance]
Beta Bionics, Inc. (BBNX)
Company Research
Source: Yahoo! Finance
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. 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
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BBNX
News
- Beta Bionics (NASDAQ:BBNX) had its price target lowered by analysts at Truist Financial Corporation from $37.00 to $25.00. They now have a "buy" rating on the stock.MarketBeat
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Beta Bionics, Inc. - BBNXPR Newswire
- SHAREHOLDER NOTICE: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Beta BionicsPR Newswire
- BBNX Investors Have Opportunity to Join Beta Bionics, Inc. Fraud Investigation with the Schall Law FirmGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Beta Bionics, Inc. - BBNXGlobeNewswire
BBNX
Earnings
- 10/28/25 - Beat
BBNX
Sec Filings
- 1/30/26 - Form 8-K
- 1/14/26 - Form 4
- 1/14/26 - Form 4
- BBNX's page on the SEC website