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# QS and MDR Violations at Sweden’s Euro Diagnostica
- URL: https://www.fdaweb.com/qs-and-mdr-violations-at-swedens-euro-diagnostica/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139826

A 1/16-1/19 FDA inspection at Euro Diagnostica AB, Skane, Sweden, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of multiple Class 2 *in vitro* diagnostic devices, including the Euro-Diagnostica CCPoint. A 9/20 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm578374.htm?ref=fdaweb.com) says the violations were: 

- failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to document all corrective and preventive action activities and their results;
- failing to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and corrected at appropriate stages of the device’s design development;
- failing to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, and to document in the device history file the results of the design verification, including identification of the design method(s), the date, and the individual(s) performing the verification;
- failing to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine effectiveness of the quality system;
- failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

Euro Diagnostica was told to respond with a list of specific steps taken to correct the violations and prevent them from recurring, documentation of the corrections and/or corrective action, and a timetable for completion.