FDA 483 - Euro Diagnostica AB - January 19, 2017

Euro Diagnostica AB in Malmo, Sweden, was inspected by the FDA from January 16-19, 2017. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for medical device reporting, complaint handling, design control, corrective and preventive actions, and internal quality audits. These issues indicate a lack of robust quality management practices for a medical device manufacturer.