FDA 483 - Luminex Corporation - January 13, 2023

Luminex Corporation, a medical device manufacturer in Austin, TX, was cited for three significant issues during an FDA inspection. The firm failed to adequately revalidate processes after changes or deviations, including a VERIGENE Processor SP verification method and ARIES assay cassette manufacturing, which led to a Class III recall. Additionally, the company's corrective and preventive action procedures were found inadequate, a repeat observation, and several Medical Device Reports for AIRES SARS-CoV-2 Assay malfunctions were not submitted within the required 30-day timeframe, potentially delaying diagnoses and risking patient health.