FDA 483 - Suez Treatment Solutions, Inc. - September 16, 2022

An FDA inspection of Suez Treatment Solutions, Inc. in Arlington, TX, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for process controls, handling of nonconforming products, acceptance activities, and complaint management. These issues indicate a systemic lack of adherence to quality assurance requirements.