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

The FDA issued a Warning Letter to Beta Bionics, Inc. on January 28, 2026, following an inspection from June 9 to June 26, 2025. The inspection revealed significant violations in the manufacturing and reporting for their iLet Bionic Pancreas System, which includes the iLet Dosing Decision Software and iLet ACE Pump.

The letter highlighted multiple violations of the Quality System Regulation (21 CFR Part 820). Beta Bionics failed to adequately establish and maintain procedures for corrective and preventive actions (CAPA), evidenced by insufficient analysis of quality data, failure to implement CAPAs for serious device malfunctions (e.g., faulty motors, use errors leading to hypoglycemia, damaged displays), and inadequate verification of effectiveness for these actions. Investigations into nonconforming products, like delayed glucose readings and defective mainboards, were often undocumented or lacked appropriate follow-up.

Furthermore, the company failed to adequately integrate post-market safety data into its design validation and risk analysis (21 CFR 820.30(g)), overlooking risks such as printed circuit board assembly failures, involuntary insulin over-infusion, and leaking cartridges/connectors. Complaint handling procedures were also deficient, with numerous serious events (e.g., hyperglycemia, DKA, infusion set failures) not being properly investigated or escalated (21 CFR 820.198(a)).

The FDA also cited violations of Medical Device Reporting (MDR) regulations (21 CFR Part 803), noting failures to timely report serious injuries (e.g., hyperglycemia, severe hypoglycemia requiring intervention) and device malfunctions likely to cause serious injury or death. Additionally, the company failed to submit required reports for Corrections and Removals (21 CFR Part 806) within 10 working days, specifically for critical software updates addressing delayed glucose readings and cybersecurity vulnerabilities.

Beta Bionics must provide a comprehensive written response within fifteen business days, detailing specific corrective actions, a plan to prevent recurrence, and a timetable for implementation. Non-compliance could result in severe regulatory actions, including seizure, injunctions, civil penalties, and impacts on federal contracts or future device approvals.