FDA 483 - Beta Bionics, Inc - June 26, 2025

Beta Bionics, Inc. received a Form FDA-483 for deficiencies in its quality system related to the iLet Bionic Pancreas System. The inspection revealed significant issues with timely Medical Device Reporting, inadequate complaint handling procedures, and insufficient corrective and preventive actions. These deficiencies led to failures in reporting serious adverse events like diabetic ketoacidosis and severe hypoglycemia, and a lack of proper investigation and risk mitigation for device malfunctions and user errors.