Cardinal HealthAugust 15, 2025

FDA 483 - Cardinal Health - August 15, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Cardinal Health

Record Details

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.

Company: Cardinal Health
Inspection Date: August 15, 2025
Product Type: Drugs
Office: Chicago District Office
Person: Jeffrey P. Raimondi (Consumer Safety Officer)

Open in Dashboard

ID · 3d36b197-2d97-455a-9f2b-69a0db2820e6