FDA 483 - Cardinal Health - August 15, 2025

Cardinal Health, Inc. in Glendale Heights, IL, a PET drug manufacturer, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in documenting all steps of the PET drug production process, specifically regarding re-drawn QC samples. Additionally, the firm's laboratory testing procedures for bacterial endotoxin testing were found to be inconsistent with the original method validation.