FDA 483 - Magnatone Hearing Aid Corp - December 10, 2019

The FDA inspected Magnatone Hearing Aid Corp. DBA Persona Medical in Casselberry, FL, from December 3-10, 2019. The inspection revealed significant deficiencies across multiple design control procedures, including design validation, design input, purchasing controls, design risk analysis, and design change processes for their medical devices, particularly hearing aids and associated software. These issues indicate a lack of adequate controls to ensure product safety and compliance.