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

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/b19c8f0a-7db6-4063-9417-a60a4caceb87

> 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: Detroit District Office
- Summary: An FDA inspection of Cardinal Health 414, LLC in Indianapolis, IN, revealed significant deficiencies in quality control and facility maintenance. The firm failed to thoroughly investigate out-of-specification results and microbial contamination, and its sampling methods for bioburden testing were found to be unrepresentative. Additionally, critical production line equipment was damaged and lacked proper repair documentation, indicating a risk to drug product quality and safety.

## Related Documents

- [483 - 2025-09-12](https://www.keypedia.com/records/483/cardinal-health-414-llc/e39e7d8d-6e6f-469e-aac3-e2700a45ee0f)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03