FDA 483 - Medion Grifols Diagnostics AG - April 30, 2024

Medion Grifols Diagnostics AG, an IVD manufacturer in Dudingen, Switzerland, was cited for significant quality system deficiencies. The inspection revealed failures in product validation, lack of environmental control procedures, inadequate documentation of corrective and preventive actions, and a critical failure to submit Medical Device Reports for device malfunctions that could lead to serious injury. These issues indicate a systemic breakdown in quality management practices with potential impact on product safety and efficacy.