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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.