# FDA 483 - Cardinal Health 414 LLC - January 23, 2026

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/12b97f9e-7b41-426d-83b0-515bce455b5d

> FDA 483 for Cardinal Health 414 LLC on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414 LLC
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Cardinal Health 414 LLC in Phoenix, AZ, a PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for equipment cleaning, leading to Aspergillus contamination in manufacturing areas, and facility conditions that failed to prevent product contamination. These issues pose a risk to the quality and sterility of PET drugs intended for patient infusion.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/cardinal-health-414-llc/9ba62f77-6300-4af0-ac3d-b6f9f782038b

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face