FDA 483 - Reliance Mobility, LLC - April 10, 2018

An FDA inspection of Reliance Mobility, LLC in Columbia, TN, a manufacturer of dedicated speech generating devices, revealed numerous significant deficiencies in its quality system. The firm failed to establish or adequately maintain essential procedures and records for design control, device master and history records, complaint handling, medical device reporting, corrective and preventive actions, and quality audits. These findings indicate a broad lack of compliance with fundamental regulatory requirements for medical device manufacturing.