Enterra Medical, Inc. – FDA 483, May 4, 2026

Enterra Medical, Inc. in St. Louis Park, MN, received five observations during an FDA inspection concerning its Class III medical device for chronic nausea and vomiting. The inspection revealed significant deficiencies in process validation, risk management documentation and implementation, the application of risk-based quality management, evaluation of design changes, and supplier management. These issues indicate systemic problems in the firm's quality system that could impact device safety and effectiveness.