Baxter Healthcare Corporation – FDA 483, Aug 1, 2024
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.
ID · 02bbb3b0-c243-4877-9c00-8ffe4e0cac64
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