Cardinal Health, Inc. – FDA 483, Aug 15, 2025

During an inspection conducted from August 11-15, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Cardinal Health, Inc., identifying significant observations related to their PET drug production and quality control processes. The inspection highlighted deficiencies under the Federal Food, Drug, and Cosmetic Act.

One primary observation involved the absence of complete master production and control records. Specifically, the company failed to consistently document all steps in the PET drug production process, including instances where samples were re-drawn for Quality Control (QC) release testing. An example cited was a batch that initially failed a bacterial endotoxin test, necessitating a re-draw that was not recorded in the batch production records.

A second critical finding concerned laboratory testing procedures. The FDA noted that the bacterial endotoxin testing procedure for PET drug products was inconsistent with its original method validation. This discrepancy could compromise the assurance that drug products conform to established standards for identity, strength, quality, and purity.

Cardinal Health is required to address these observations by implementing corrective actions. These actions are crucial to ensure adherence to regulatory standards for manufacturing and quality control, thereby safeguarding product quality and patient safety. The company must provide a formal response outlining its plans to rectify these identified issues.