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

Beta Bionics, Inc. in Irvine, CA, was cited for significant deficiencies in its quality system, particularly concerning medical device reporting, complaint handling, corrective and preventive actions, and risk analysis for its iLet Bionic Pancreas System. The inspection revealed failures to report serious injuries and malfunctions, inadequate investigation and documentation of product issues, and insufficient verification of corrective actions, posing potential risks to patient health.