Takeda Manufacturing Italia SPANovember 12, 2024

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

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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.

Company: Takeda Manufacturing Italia SPA
Inspection Date: November 12, 2024
Product Type: Biologics
Office: Office of Inspections and Investigations
People: Alan L. Truong
Shafiq S. Ahadi (Investigator)

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ID · 18b6e9a8-1cd3-4416-b558-2eb268ec327a