Luminex Corporation – FDA EIR, Jan 20, 2023

Luminex Corporation, a manufacturer of Class 2 VERIGENE in vitro diagnostic assays in Northbrook, IL, underwent an FDA inspection from January 17-20, 2023. This for-cause inspection, guided by the Quality System Inspection Technique (QSIT) and relevant compliance programs, specifically identified a violation related to Medical Device Reporting (MDR) procedures, citing 21 CFR 803.17. The main issue on the FDA Form 483 detailed inadequate implementation of written MDR procedures. This included failures to submit initial and supplemental MDRs within the mandated 30-day timeframe and to include all required information. Specific examples cited late submissions and missing critical follow-up details on device malfunctions, such as "No Call" malfunctions in diagnostic assays, which could potentially delay diagnoses and cause serious harm. Additionally, the FDA verbally noted two concerns: the company had not submitted required updates for an ongoing recall (RES 89051) and its official product listing with the FDA was not current, still reflecting discontinued test kits. Luminex Corporation's management acknowledged the findings, promising to correct the identified deficiencies. They committed to submitting a formal written response within 15 business days to address the FDA 483 observation and indicated plans to update their product listings. The agency emphasized that legal sanctions, including injunctions, remain possibilities if compliance is not achieved.