FDA 483 - Flextronics International USA, Inc - April 19, 2022

An FDA inspection of Flextronics International USA, Inc. in Buffalo Grove, IL, a contract medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to adequately review and investigate MDR-reportable complaints, maintain proper documentation for corrective and preventive actions, and ensure personnel training was properly documented. These issues indicate a lack of robust quality control over critical manufacturing and post-market surveillance processes.