FDA 483 - Vision Chips Inc - February 27, 2026

Vision Chips, Inc. in Laguna Niguel, CA, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation concerning the firm's failure to implement Unique Device Identifier (UDI) requirements for its Class II medical image management and processing system, Observer 7. This indicates a non-compliance with labeling regulations for medical devices.