Enterix, Inc. – FDA 483, Mar 10, 2023

Enterix, Inc. in Edison, NJ, was inspected regarding its manufacturing of InSure ONE fecal immunochemical test kits. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for corrective and preventive actions, control of nonconforming products, equipment calibration, and employee training. These issues indicate a lack of robust quality management practices.