# FDA 483 - Cardinal Health 414, LLC - September 12, 2025

Source: https://www.globalkeysolutions.net/records/483/cardinal-health-414-llc/e39e7d8d-6e6f-469e-aac3-e2700a45ee0f

> FDA 483 for Cardinal Health 414, LLC on September 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414, LLC
- Inspection Date: 2025-09-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Cardinal Health 414, LLC in Indianapolis, IN, received a Form 483 with three observations related to manufacturing practices for radiopharmaceutical drug products. The inspection revealed failures in thoroughly investigating unexplained discrepancies, non-representative sampling for bioburden testing, and inadequate maintenance of equipment on the production line. These issues indicate potential risks to the safety, identity, strength, quality, or purity of their drug products.

## Related Documents

- [483 - 2025-09-12](https://www.globalkeysolutions.net/records/483/cardinal-health-414-llc/b19c8f0a-7db6-4063-9417-a60a4caceb87)

## Related Officers

- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Carolina D. Vasquez](https://www.globalkeysolutions.net/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.globalkeysolutions.net/companies/cardinal-health-414-llc/b1d6d59b-695c-42a4-8272-d3e5a96de306

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0