FDA 483 - Kamada, Ltd. - February 03, 2010

An FDA Pre-License Inspection of Kamada, Ltd. in Negev, Israel, for their Alpha-1-Proteinase Inhibitor product, identified 13 significant observations. The findings highlight critical deficiencies in aseptic processing, sterilization validation, environmental monitoring, and quality control documentation. These issues indicate a need for improved controls to ensure product sterility and overall quality.