FDA 483 - MobileHelp, LLC - March 11, 2022

An FDA inspection of MobileHelp, LLC, a manufacturer of Medical Alert Systems in Boca Raton, FL, revealed significant deficiencies in their quality management system. The firm was cited for inadequate procedures related to corrective and preventive actions, organizational structure, complaint handling, and device history records. These observations indicate a need for improved controls to ensure devices are designed and produced in accordance with regulatory requirements.