# FDA 483 - Cardinal Health - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/cardinal-health/3d36b197-2d97-455a-9f2b-69a0db2820e6

> FDA 483 for Cardinal Health on August 15, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cardinal Health
- Inspection Date: 2025-08-15
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2023-12-20](https://www.globalkeysolutions.net/records/warning_letter/cardinal-health/d7ff3af8-8245-48bb-a43b-bdb61a9102d4)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/cardinal-health/c79cee39-5a53-4323-a195-ca4aa41a84e1

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669