FDA 483 - Beta Bionics, Inc - June 26, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 8e8c3dfd-995e-4c6b-a384-b8c52791b079