FDA 483 - Biometrix Ltd. - August 15, 2019

An FDA inspection of Biometrix Ltd. in Jerusalem, Israel, a contract manufacturer, revealed significant deficiencies in its design control procedures. The firm failed to adequately establish procedures for design changes and design transfer, and did not properly document design review results for its medical devices, including the Thorametrix Dry device. These issues indicate a lack of robust quality system practices for medical device development.