Triangle Machine, Inc. – FDA 483, Apr 15, 2026

Triangle Machine, Inc. in South Bend, IN, a medical device manufacturer, received seven observations during an FDA inspection. The observations highlight significant deficiencies in the firm's quality management system, primarily concerning inadequate documentation and control procedures. These issues span risk management, supplier oversight, change control, production processes, design transfer, statistical techniques, and internal audits, indicating a need for comprehensive quality system improvements.