The FDA has rebuked Baxter in a lengthy warning letter outlining production violations that fueled, in part, in a trio of recalls earlier this year.
Although the warning letter, issued Sept. 29 and posted on the FDA's website this week, was primarily focused on the company’s plant in Round Lake, Illinois, the regulatory agency pointed out similar violations had been uncovered at other sites. Inspectors visited the site between March 23 and April 2, with Baxter ultimately receiving the lesser reprimand of a Form 483 earlier this year.
“These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate,” the FDA said. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”
This past summer, Baxter issued recalls of two lots of sodium chloride injection, one lot of cefazolin in dextrose injection and one lot of anticoagulant sodium citrate solution due to the potential presence of particulate matter such as fiberglass, cardboard and stainless steel.
The company has also been hit with several FDA Form 483s since 2023, with the most recent issued this past April as a result of an inspection of the Round Lake facility.
In the warning letter, the agency outlined four major areas of infractions that included not keeping separate different sterile drugs produced at the site, lacking proper procedures to prevent microbial contamination, failing to establish laboratory controls to test for strength, quality and purity of products, and not thoroughly investigating unexplained problems or failures of a batch and whether that batch had been distributed.
The agency said Baxter’s internal investigations of container-closure integrity failures didn’t “address the significantly increased rate of leak defects” of injectable drug products.
“You did not implement sufficient CAPA to ensure remediation of your final inspection program,” the FDA added. “Further, since 2023, media fill units were found leaking during incubation and you have received numerous leak complaints for marketed products.”
On the particulate issue, the FDA noted that Baxter's manual visual inspection program was lacking, with operators "not properly qualified." Further, the company's broader approach to spotting product defects "compromises reliable detection and the quality of data inputs to support batch release and CAPA decisions made by your quality unit," the regulator said.
While those issues had been raised in prior years, Baxter had not acted quickly enough to rectify the situation, the FDA alleged, adding that the particulate-related cefazolin recall Baxter initiated this summer only happened after it was contacted by the regulator.
Another concern of inspectors who visited Baxter's Illinois site involved lack of adequate separation between antibiotic cephalosporins and other drug product, flagging "several instances" in which Baxter's environmental monitoring program detected cephalosporin contamination in verboten sections of the plant since Jan. 2025.
The agency warned that failing to address the ongoing manufacturing issues could result in Baxter losing consideration for U.S. federal agency contracts and having its Export Certification withheld. The FDA can also put a stop to any new drug manufacturing applications from the company, if warranted.
The agency is also recommending that Baxter schedule a meeting to discuss its corrective actions, once it has submitted its response to the FDA write-up.