483
Flextronics America LLCFDA 483 - Flextronics America LLC - October 30, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · eddf70a6-958e-4c4e-a619-d34c9470c3ed