FDA 483 - Takeda Manufacturing Italia SPA - November 15, 2019

Baxter Manufacturing S.p.A. in Rieti, Italy, was inspected and cited for multiple deficiencies related to manufacturing controls, quality systems, and documentation practices. Observations include inadequate cleaning validation documentation, failure to follow procedures, deficient verification checks, incomplete investigations, and insufficient stability studies for temperature excursions. These issues indicate significant concerns regarding product quality and data integrity.