FDA 483 - Silhouet-Tone (USA), Inc - October 21, 2022

An FDA inspection of Silhouet-Tone (USA), Inc. in Doral, FL, an initial importer and distributor, revealed significant deficiencies in their quality system. The firm lacked adequate written procedures for complaint handling, Medical Device Reporting (MDR), corrective and preventive actions (CAPA), equipment calibration, and environmental controls for electrostatic discharge (ESD) in the product repair room. These observations indicate a systemic failure to establish and implement essential quality management processes for medical devices.