FDA 483 - CGX, LLC - April 03, 2025

CGX, LLC, a medical device manufacturer in San Diego, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for complaint handling, failure to implement Unique Device Identifiers (UDI) for its Quick-20m EEG headset, and a lack of proper quality reaudits and supplier qualification records. These issues indicate a need for comprehensive improvements in the firm's quality management practices.