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# QS Violations Found in Silfradent Inspection
- URL: https://www.fdaweb.com/qs-violations-found-in-silfradent-inspection/
- Published: 2020-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:05:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146229

A 7/29-8/1/19 FDA inspection at Silfradent Srl, Santa Sofia, Italy, found violations of the Quality System regulation in the firm’s manufacturing of the Surgybone SB 300NA. A just-released [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silfradent-srl-592502-10282019?ref=fdaweb.com) says specific violations were: 

- failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met;
- failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally dedicated unit; and
- failing to develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses to the inspection observations were found to be inadequate or their adequacy could not be determined. Silfradent was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completing the corrections.