FDA 483 - Chief Power Chair, LLC - July 30, 2024

An FDA inspection of Chief Power Chair, LLC in Tucson, AZ, revealed multiple significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately maintain device master and history records, establish proper procedures for quality audits, management reviews, and servicing activities, and control nonconforming products. These issues indicate a systemic lack of adherence to quality system regulations.