The FDA has warned Baxter International over significant manufacturing violations at its Baxter Healthcare drug manufacturing facility in Round Lake, Ill., including deficiencies involving contamination controls and sterile injectable production.
The agency identified the violations during a March 23-April 2 inspection, according to a Sept. 29 warning letter. The FDA said environmental monitoring had detected cephalosporin in multiple areas outside the intended production area since January 2025 and cited deficiencies in Baxter’s monitoring program.
The FDA also identified deficiencies involving aseptic processing, visual inspection of sterile injectable drugs and investigations into leaking products and sterility failures. The agency said Baxter’s current equipment, process and airflow design posed “excessive contamination risk.”
The agency also cited problems with Baxter’s investigation of a 2025 cefazolin sterility failure and said the company had identified particulate matter in retain and complaint samples after products were released.
The FDA said similar manufacturing violations had been cited at other Baxter facilities, which it said demonstrated inadequate management oversight and control over drug manufacturing. On July 17, Baxter agreed to voluntarily recall one lot of cefazolin and various other drugs in U.S. distribution after an FDA recommendation.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
