Baxter Quality Control Flawed, FDA Says

Baxter International Inc.’s health care unit was cited for flaws in quality control procedures at its Irvine plant, which makes pulmonary artery catheters, according to a government letter released Tuesday.

In the March 12 letter, U.S. Food and Drug Administration officials cited Baxter for not having adequately tested the software that runs its manufacturing process.

Inspectors who visited the company’s plant in Irvine also found that the company didn’t have enough evidence that the plant’s molding and forming procedures would produce catheters that met quality standards, the letter said.

The FDA told Baxter last week that changes it had made appear to be “adequate,” said Deborah Spak, a spokeswoman for Baxter.

“There were not any questions raised about the safety or efficacy of our products that are produced at that facility,” she said.

The March 12 letter did warn that the problems discovered might be “symptomatic of serious underlying problems,” at the company.

Baxter officials met with the FDA in March, before the agency sent the letter, and the company had begun correcting its software and manufacturing problems. Still, the FDA said in the letter that another inspection would be required to “assure that your corrections are adequate.”

The FDA sends hundreds of warning letters to companies each year, and only a small minority result in any significant agency action. However, the letters can be the last notice before the FDA takes steps such as holding up approvals of new products or pursuing civil penalties.