FDA 483 - Magnatone Hearing Aid Corp - July 14, 2025

Magnatone Hearing Aid Corporation in Casselberry, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to ensure its quality policy was implemented, did not conduct management reviews or quality audits, and lacked adequate procedures for corrective and preventive actions, complaint handling, and medical device reporting. These issues indicate a broad breakdown in quality management.