FDA 483 - Matheson Tri-Gas, Inc - December 09, 2022

An FDA inspection of Matheson Tri-Gas, Inc. in Dallas, TX, a medical gas manufacturer, revealed a significant lapse in quality control. The firm failed to conduct annual product reviews for all trans-filled drug products, including Oxygen, USP, Carbon Dioxide, USP, Nitrogen, NF, and Nitrous Oxide, USP. This indicates a failure to maintain records for evaluating product quality and identifying opportunities for continuous process improvement.