FDA 483 - Flextronics America LLC - October 30, 2025

An FDA inspection of Flextronics America LLC in Austin, TX, a Class II medical device manufacturer, identified three significant observations. The firm failed to adequately validate manufacturing processes for its Continuous Glucose Monitoring system, lacked established procedures for acceptance activities to ensure device functionality, and did not properly document corrective and preventive actions related to device failures and process controls.