FDA 483 - Ekcomed LLC - September 12, 2019

An FDA inspection of Lloyd Industries, Inc. in Saint Charles, MO, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes and software, control non-conforming products, establish proper rework procedures, and implement effective corrective and preventive actions. These issues indicate a lack of robust quality management for their medical devices, including the DA-2006P Defibrillator Analyzer.