FDA 483 - Acorn Stairlifts, Inc - July 16, 2021

Acorn Stairlifts, Inc. in Belle Isle, FL, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to report a critical device correction to the FDA, demonstrated inadequate corrective and preventive action procedures, and lacked proper purchasing controls for its suppliers, particularly concerning validation studies for stairlift seats. These issues indicate a concerning lack of adherence to regulatory requirements for medical device quality systems.