FDA 483 - Eurofins Viracor, LLC. - April 19, 2023

An FDA inspection of Eurofins Viracor, LLC. in Lenexa, KS, a manufacturer of medical devices, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, design validation, design verification, and complaint handling for their Class II ImmuKnow Immune Cell Function Assay. These issues indicate a lack of robust quality controls and could impact device safety and effectiveness.