FDA 483 - ASD Sleep, LLC dba American Sleep Dentistry - September 09, 2022

An FDA inspection of ASD Sleep, LLC dba American Sleep Dentistry in Cedar City, UT, a medical device manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for controlling nonconforming products and design changes, and did not properly maintain device history and master records. Additionally, labeling was not sufficiently examined, and Unique Device Identifier (UDI) implementation was lacking.