Baxter International Inc. earned a warning letter from the Food & Drug Administration over the labeling and manufacture of its Isolex device used to treat cancer.
The FDA letter, sent to Baxter chairman, president and CEO Robert Parkinson Jr. Sept. 10, said the label on the device is misleading and the manufacturing process for the product doesn’t meet federal requirements.
Baxter spokeswoman Mavis Prall told the Reuters news service that the company corrected one of the issues the watchdog agency flagged and “we continue to work with the FDA to address other issues.”
Isolex annual sales are about $1 million, meaning it’s a “tiny fraction of Baxter’s overall business,” Prall told the newswire.