483
Baxter Healthcare CorporationBaxter Healthcare Corporation – FDA 483, Sep 28, 2016
Record Details
An FDA inspection of Baxter Healthcare Corporation in Deerfield, IL, revealed significant deficiencies in their pharmacovigilance system. The firm failed to promptly review adverse drug experience information, leading to incorrect identification and reporting of numerous serious and unexpected adverse events. This non-compliance stemmed from issues within specific programs and a broader culture of non-compliance, including inadequate training and adherence to internal policies.
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ID · 37a42605-354d-43f4-a6ea-fe8429351fda
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