FDA WARNING_LETTER - Abbott Diabetes Care, Inc. - October 23, 2025

The FDA issued a Warning Letter to Abbott Diabetes Care, Inc. on January 23, 2026, following an inspection from October 14 to October 23, 2025. The inspection found that the company"s FreeStyle Libre Flash and Continuous Glucose Monitoring Systems, including the FreeStyle Libre 3, were in violation of the Quality System Regulation (21 CFR Part 820) and specific controls for integrated continuous glucose monitoring (iCGM) devices, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure to adequately establish procedures for design transfer, specifically concerning the translation of performance specifications, such as sensor glucose accuracy, to third-party manufacturers. The FDA also cited the company for not properly establishing finished device acceptance procedures, noting that fully assembled, sterilized, and packaged devices were released without final accuracy performance testing. Furthermore, Abbott failed to implement statistically valid techniques for acceptance criteria and sampling plans, and inadequately validated its manufacturing and release controls to ensure ongoing accuracy performance.

The FDA deemed Abbott"s responses to the inspection observations inadequate, indicating that proposed interim measures were not validated or sufficiently comprehensive. Abbott Diabetes Care, Inc. is required to take prompt action to correct these systemic violations. They must submit a written response to the FDA within fifteen business days detailing the specific corrective actions taken, including documentation and a timeline for completion, to prevent recurrence. Failure to adequately address these issues could lead to further regulatory actions, including injunctions, seizures, and civil penalties.