FDA 483 - Baxter Healthcare Corporation - August 01, 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.