Cardinal Health 418, Inc. – FDA 483, Feb 21, 2020

An FDA inspection of Cardinal Health 418, Inc. in Aurora, CO, a pharmaceutical manufacturer, revealed significant deficiencies in equipment maintenance and cleaning validation practices. Inspectors observed poorly maintained equipment with residues and rust, and found that the firm lacked adequate cleaning procedures and a robust cleaning validation study for its manufacturing equipment. These issues raise concerns about the control over manufacturing processes and the quality of drug products.