Beta Bionics, Inc.

Warning LetterOpen

Sean Saint Chief Executive Officer Beta Bionics, Inc. 11 Hughes Irvine , CA 92618 United States (b)(6)@betabionics.comFEI 3019004087Issued Jan 28, 2026Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3019004087.

Violations10

Issue DateJan 28, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Beta Bionics, Inc.
Location: Sean Saint Chief Executive Officer Beta Bionics, Inc. 11 Hughes Irvine , CA 92618 United States (b)(6)@betabionics.com
FEI Number: 3019004087
Country: United States
Issue Date: January 28, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Beta Bionics, Inc. manufactured the iLet Bionic Pancreas System (including dosing decision software and pump components) in violation of FDA's Quality System Regulation (21 CFR Part 820). During a June 2025 inspection, investigators identified failures to establish and maintain adequate corrective and preventive action (CAPA) procedures, including inadequate analysis of quality data such as complaints to identify nonconforming products or recurring quality problems related to device malfunctions. The company's responses to FDA's inspectional observations between July and October 2025 did not adequately address these manufacturing control deficiencies.

Beta Bionics, Inc. FDA Warning Letter, January 28, 2026