# FDA 483 - Cardinal Health 414 LLC - March 18, 2021

Source: https://www.keypedia.com/records/483/cardinal-health-414-llc/4eec3de3-3a8f-4daf-8625-0b16dd0c1cf3

> FDA 483 for Cardinal Health 414 LLC on March 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardinal Health 414 LLC
- Inspection Date: 2021-03-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Cardinal Health 414 LLC in Las Vegas, NV, was inspected from March 16-18, 2021, and received a Form 483 citing a significant deficiency in production and process controls. The firm lacked adequate controls to ensure consistent production of PET drugs, specifically regarding cleaning and disinfection methods and contact times within ISO 5 hot cells and laminar air flow work stations. This indicates potential issues with the quality and purity of their PET drug products.

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/cardinal-health-414-llc/81442a7e-22ef-4ed5-bbac-2d2a5a5e5836

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b