FDA 483 - Baxter Healthcare Corporation - August 01, 2024
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The FDA inspection of Baxter Healthcare Corporation in Round Lake, IL, identified five significant issues related to drug manufacturing. These included inadequate facility separation for cephalosporin and non-cephalosporin production, a deficient visual inspection program for finished products, and a failure to thoroughly investigate discrepancies and consumer complaints. Additionally, the firm's visual inspection training was found to be inadequate, and equipment cleaning practices were insufficient, leading to potential contamination risks.
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