FDA 483 - CHEMOMOUTHPIECE, LLC DBA ICE COLD MOUTHPIECE - September 19, 2023

An FDA inspection of CHEMOMOUTHPIECE, LLC DBA ICE COLD MOUTHPIECE in Closter, NJ, a manufacturer, revealed significant deficiencies in its quality management system. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, purchasing control, and management review. These issues indicate a lack of a robust quality system to ensure product quality and compliance.