Echopixel, Inc. – FDA 483, Jan 15, 2025

An FDA inspection of Echopixel, Inc. in San Jose, CA, revealed significant deficiencies in its quality system. The firm failed to properly report a device correction/removal for malfunctioning software, inadequately maintained complaint files with conflicting dates, and did not perform quality audits at defined intervals. These observations highlight a lack of adherence to regulatory requirements for medical device manufacturers.