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

Source: https://www.globalkeysolutions.net/records/483/silhouet-tone-usa-inc/b76b4769-9a2f-4c60-a965-01f2825f231a

> FDA 483 for Silhouet-Tone (USA), Inc on October 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silhouet-Tone (USA), Inc
- Inspection Date: 2022-10-21
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/silhouet-tone-usa-inc/d12420d1-3a76-4c71-983e-81d46621877f

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6