FDA 483 - MobileHelp, LLC - March 11, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 05c7385f-141b-45fc-8838-cb3a3ad48d59