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

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.