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

Corza Medical Distribution GmbH, Austria Branch, a licensed combination product manufacturer in Linz, Austria, received an FDA Form 483 citing significant quality control and procedural deficiencies. Observations included the use of expired reagent standard curves for TachoSil product release and deficient investigations. The firm also failed to timely initiate deviations, close Out of Specification investigations, and adequately document sanitation practices in manufacturing areas.