Airgas USA LLC – FDA 483, Feb 18, 2022

An FDA inspection of Airgas USA LLC in South Salt Lake, UT, identified significant deficiencies in the control and security of drug product labels for medical gases. The firm failed to ensure adequate physical separation of labels during production and allowed unauthorized personnel unrestricted access to labeling materials. These conditions indicate a lack of proper controls, increasing the risk of label mix-ups and cross-contamination.