FDA 483 - Kamada Ltd. - March 02, 2023

During an FDA inspection conducted from February 22 to March 02, 2023, Kamada Ltd., a drug substance and drug product manufacturer, received a Form 483 listing several significant observations indicating non-compliance with regulatory expectations. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified critical issues in manufacturing practices and facility maintenance. Key observations included inadequate process validation, particularly concerning equipment use and the implementation of unvalidated "amended" procedures without proper regulatory submission or impact evaluation. For instance, specific manufacturing runs utilized non-qualified or unvalidated procedural versions, and critical process deviations were allowed to proceed without adequate corrective action. Facility conditions were also a concern, with reports of numerous power outages, recurrent water leaks affecting production areas, and frequent pressure differential excursions. These issues suggest a lack of robust facility control and maintenance. Furthermore, aseptic filling procedures exhibited deficiencies, such as product spills during critical runs not being adequately addressed in subsequent media fill studies, and insufficient environmental monitoring during product transfer line connections. Finally, the company lacked adequate written procedures for labeling drug substances, posing a risk of mix-ups. Kamada Ltd. is required to address these observations by implementing comprehensive corrective and preventive actions to ensure product quality and compliance.