FDA 483 - DIAGAST - April 19, 2024

Diagast, a Biologics IVD Manufacturer in Loos, France, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included failures in Medical Device Reporting (MDR) submission and procedures, inadequate risk analysis for blood grouping reagents, and insufficient control over storage area temperature excursions. The firm also failed to document biological deviation reports and in-process quality control activities.