FDA 483 - Corza Medical Distribution GmbH, Austria Branch - September 12, 2025

Corza Medical Distribution GmbH, Austria Branch, a licensed combination product manufacturer, was cited with three observations during an FDA inspection. The firm failed to follow established test procedures, specifically using expired reagents for standard curves for TachoSil product batches distributed in the US. Additionally, the quality control unit did not consistently follow procedures for timely deviation initiation and OOS closure, and lacked detailed written sanitation procedures for manufacturing rooms.