FDA 483 - Livongo Health, Inc. - February 04, 2016

Livongo Health, Inc. in Chicago, IL was inspected from January 25 to February 4, 2016, and received two observations. The firm failed to report a device correction for its In Touch Test Strips to the FDA and lacked established procedures for corrective and preventive actions. These issues indicate significant deficiencies in quality system management and regulatory reporting.