FDA 483 - Breathe E-Z Systems, Inc. - July 17, 2019

An FDA inspection of Breathe E-Z Systems, Inc., a manufacturer of Class II CO Sleuth Carbon Monoxide Analyzers, revealed significant deficiencies in their quality system. The firm failed to establish procedures for device history records, acceptance activities for materials and devices, and the proper handling and documentation of customer complaints. These issues indicate a lack of fundamental controls over manufacturing processes and post-market surveillance.