# FDA 483 - Eurofins Viracor, LLC. - July 26, 2019

Source: https://www.globalkeysolutions.net/records/483/eurofins-viracor-llc/aa0089f7-cb49-442f-a77d-f5855b87ed43

> FDA 483 for Eurofins Viracor, LLC. on July 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Viracor, LLC.
- Inspection Date: 2019-07-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Eurofins Viracor, Inc. in Lees Summit, MO, a manufacturer of the ImmuKnow Immune Cell Function Assay, revealed significant deficiencies in their quality system. Observations included inadequate procedures for accepting in-process product, controlling nonconforming product, and handling customer complaints. Additionally, process control procedures for laboratory equipment qualification were found to be insufficient.

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- [483 - 2023-04-19](https://www.globalkeysolutions.net/records/483/eurofins-viracor-llc/e9f98653-7da8-4d9c-81fa-4f17aecd0985)

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/eurofins-viracor-llc/17deff81-615f-4364-acfb-5b62e37f7048

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8