Eurofins Viracor, LLC.July 26, 2019

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

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Record Details

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.

Company: Eurofins Viracor, LLC.
Inspection Date: July 26, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - West II
Person: Eric C. Fox

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