Luminex Corporation – FDA 483, Oct 22, 2021

An FDA inspection of Luminex Corporation in Northbrook, IL, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to adequately establish servicing procedures, report device removals posing health risks to the FDA, and maintain effective corrective and preventive action procedures. Several issues were repeat observations from prior inspections and a Warning Letter, indicating a persistent lack of compliance.