FDA 483 - Luminex Corporation - February 14, 2020

Luminex Corporation, a medical device manufacturer in Northbrook, IL, was cited for four observations related to its quality system. The inspection revealed deficiencies in corrective and preventive actions, process validation, reporting of device removals, and monitoring of validated process parameters for its Verigene SP instruments. These issues indicate a lack of adherence to established procedures and regulatory expectations for medical device quality management.