FDA 483 - Kamada - Production Plant

Kamada Ltd., a drug substance and product manufacturer in MP Negev, Israel, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process validation and use of unvalidated procedures for Cytogam manufacturing, facilities not in a state of good repair with recurring power outages and water leaks, and issues during aseptic filling setup. Additionally, the firm lacked adequate written procedures for drug substance labeling.