Section: Violations of 21 CFR 820.75(a): Validation Failures in CGM Assembly

The issuance of FDA Warning Letter CMS 722180 on January 27 2026 marks a terminal failure in the manufacturing controls at Flex Ltd. The facility in Austin Texas serves as a primary contract manufacturing node for Class III Continuous Glucose Monitoring (CGM) systems. FDA investigators documented a specific violation of 21 CFR 820.75(a). This statute mandates that any process whose output cannot be fully verified by subsequent inspection and test must be validated with a high degree of assurance. Flex failed to provide this assurance. The manufacturing process for the CGM sensor "puck" was not validated. The consequence is the distribution of adulterated medical devices into the patient supply chain. The specific mechanism of failure involves the automated transfer of Printed Circuit Board Assemblies (PCBAs) onto the sensor housing. This operation requires micron-level precision to ensure electrical connectivity without damaging the delicate connector leads.