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# QS Violations at Sweden’s Sonesta Medical
- URL: https://www.fdaweb.com/qs-violations-at-swedens-sonesta-medical/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156018

A 6/5-6/7/2023 FDA inspection at Sonesta Medical AB in Solna, Sweden, found Quality System Regulation violations in the firm’s manufacturing of a radiographic table and two cystometric tables. A just-released 9/22/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sonesta-medical-ab-667325-09222023?ref=fdaweb.com) says the specific violations were failing to establish and maintain procedures:

- to ensure that all purchased or otherwise received products and services conform to specific requirements;
- for receiving, reviewing, and evaluating complaints by a formally designated unit;
- to ensure that the design requirements relating to a device are appropriate and address the intended device use;
- for validating the device design under defined operating conditions on initial production units, lots, or batches, or their equivalents;
- for the identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation;
- to control all documents.

The letter says the firm failed to respond to two of the inspection observations and its responses to the remaining four were inadequate.

Sonesta was told to respond with a list of specific steps it has taken to respond to the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.