FDA WARNING_LETTER - Flextronics America LLC - October 30, 2025

The FDA issued a Warning Letter to Flextronics America LLC following an inspection at its Austin, TX facility from October 20-30, 2025. The company, a contract manufacturer of Continuous Glucose Monitors, was found to be in violation of the Quality System regulation (21 CFR Part 820), making its devices adulterated under the Federal Food, Drug, and Cosmetic Act.Key violations include the failure to adequately validate manufacturing processes, specifically concerning the puck assembly of CGM sensors. Uncontrolled adjustments to equipment, responsible for loading components, led to sensor damage and nonconforming products over several years, without defined settings or acceptable ranges. The firm"s process validation did not demonstrate consistent product production.Additionally, Flextronics failed to adequately establish and maintain procedures for corrective and preventive actions (CAPA). A CAPA opened in April 2025 did not effectively address the recurrence of broken components caused by improper equipment alignment, as corrective maintenance continued without a defined specification.The FDA deemed the company"s responses inadequate due to incomplete revalidation and unverified CAPA effectiveness. Flextronics is required to take prompt action, notify the FDA within 15 business days with details of corrections, preventative measures, and supporting documentation. Failure to comply could lead to severe regulatory actions, including injunctions and impact on federal contracts.