FDA Warns Baxter over Complaint Reporting

In a June 3 letter, the U.S. Food and Drug Administration warned Baxter International for not properly reporting complaints about its dialysis systems.

Click HERE to read the FDA letter, which was released June 29.

The FDA inspected Baxter’s McGraw Park, Ill., facility between November and December 2009, and concluded that the company didn’t have internal systems in place to ensure timely reporting to the FDA of adverse events with Baxter products.

“The warning letter really pertains to the process by which we analyze and address product complaints ... and how we report that relevant information to FDA," Baxter spokeswoman Erin Gardiner told Reuters on July 29.

She also told Reuters that Baxter “has initiated changes to its reporting processes and complaint systems at its McGraw Park operations and is working with FDA to address remaining issues.”