Enterix, Inc. – FDA 483, Aug 10, 2026

Enterix, Inc. in Edison, NJ, a medical device manufacturer, was cited for significant deficiencies in its quality management system. The inspection revealed inadequate application of risk-based approaches, including missing risk controls and management plans for its InSure ONE device. Additionally, the firm lacked proper procedures for customer feedback, misclassifying complaints as inquiries, and failed to implement adequate corrective actions for nonconformities by not opening required CAPAs.