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

The FDA issued a Warning Letter to Beta Bionics, Inc., following an inspection from June 9-26, 2025, concerning its iLet Bionic Pancreas System, including the iLet Dosing Decision Software and iLet ACE Pump. The inspection found significant violations of the Quality System Regulation (21 CFR Part 820), Medical Device Reporting (21 CFR Part 803), and Corrections and Removals (21 CFR Part 806) regulations, indicating the devices are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

Key quality system deficiencies included inadequate corrective and preventive action (CAPA) procedures, such as failing to properly analyze complaint data for device malfunctions (e.g., faulty motors, hypoglycemic events due to user error) and not adequately verifying CAPA effectiveness. The firm also failed to incorporate post-market safety data into its risk management processes, neglecting risks like printed circuit board assembly failures, involuntary meal announcements, and leaking insulin cartridges. Complaint handling was cited for insufficient investigation of device failures and inadequate record-keeping. Additionally, the company failed to control nonconforming products, with issues like defective mainboards not being properly investigated or addressed with suppliers.

Significant Medical Device Reporting (MDR) violations included not reporting serious injuries (e.g., hyperglycemia, hypoglycemia requiring medical intervention) and device malfunctions (e.g., component failures, touchscreen issues) within the required 30-day timeframe. The company also failed to submit timely reports for device corrections and removals, specifically for software updates addressing delayed glucose readings and cybersecurity vulnerabilities.

Beta Bionics must provide a written response within 15 business days, detailing specific corrective actions, a prevention plan, and a timetable for ongoing activities. Failure to comply may lead to severe regulatory actions, including injunctions, civil penalties, and impacts on future device approvals and contracts.