FDA 483 - Takeda Manufacturing Italia SPA - November 12, 2024

Takeda Manufacturing Italia SPA in Cittaducale, Italy, underwent an FDA inspection from November 4-12, 2024, focusing on plasma manufacturing. The inspection revealed significant deficiencies related to batch production records, adherence to written procedures, and inadequate cleaning and maintenance of equipment. These issues indicate a moderate level of non-compliance with good manufacturing practices.