483
Takeda Manufacturing Italia SPATakeda Manufacturing Italia SPA – FDA 483, Nov 15, 2019
Record Details
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.
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ID · 54cd2ab3-3bed-4e90-ae1a-68513f3fbeb6
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