FDA 483 - Kamada - Production Plant

An FDA inspection of Kamada Ltd., a drug substance and drug product manufacturer in MP Negev, Israel, revealed significant deficiencies in their manufacturing operations. Observations included inadequate process validation, failure to follow internal SOPs and use of unvalidated procedures, poor facility maintenance with power outages and water leaks, and issues with aseptic filling and product labeling. These findings indicate a lack of robust quality control and adherence to good manufacturing practices.