FDA 483 - Triangle Machine, Inc. - April 27, 2022

Triangle Machine, Inc. in South Bend, IN, a device manufacturer, was cited for multiple significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately maintain device history records, control nonconforming products, establish complaint handling procedures, conduct quality audits, and perform management reviews. These issues indicate a systemic lack of adherence to established quality system requirements.