FDA Warns Baxter Over Cross Contamination Risks in Injectable Drug Plant

The FDA has issued a warning letter to Baxter International following an inspection of its Round Lake, Illinois manufacturing facility, which produces injectable drug products including cephalosporins alongside other drug lines in the same building, according to the FDA warning letter.

Inspectors found that Baxter's environmental monitoring program had repeatedly detected cephalosporin, a beta lactam compound, in areas of the facility meant to be physically and ventilation separated from it since January 2025. The agency said the monitoring setup itself was inadequate to catch this cross contamination promptly: sampling was too limited in scope and location, swab methods were not properly validated for low level detection, and some samples were analyzed after they should have expired. The letter also notes that Baxter discarded several failing cephalosporin samples before they could be further investigated, and that testing of other drug products for contamination relied on a single unit per batch, which the FDA says is unlikely to catch contamination that is unevenly distributed.

Because of these CGMP violations, the FDA states the affected drug products are considered adulterated under federal law. Baxter has responded with planned corrective steps, but the agency says the response does not fully explain how complete separation between production lines will be achieved going forward.

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