# FDA 483 - Cardinal Health 414 LLC - April 03, 2026

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/df8baf5c-d499-47e5-a6d6-4010ec023f24

> FDA 483 for Cardinal Health 414 LLC on April 03, 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: 2026-04-03
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Cardinal Health 414 LLC in Memphis, TN, revealed a significant issue with equipment suitability. The firm failed to implement procedures and document activities to ensure equipment is suitable for its intended purposes, specifically regarding a low-temperature incubator. This lapse led to the continued use of a malfunctioning incubator for critical samples without proper requalification, potentially affecting the quality of PET drugs.

## Related Documents

- [483 - 2025-07-01](https://www.keypedia.com/records/483/cardinal-health-414-llc/f0c5a8a4-60e0-4988-9ffe-0fa07b6044b9)

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/cardinal-health-414-llc/4d8cc8c0-4648-41d7-8a17-a5790b26e3bf

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea