FDA never inspected plant tied to defective drug

NEW YORK (CNNMoney.com) -- The active ingredient in a blood-thinning medication made by Baxter International Inc, which is being blamed for causing allergic reactions, was reportedly manufactured at a Chinese facility that was never inspected by the the U.S. Food and Drug Administration, according to a report in The Wall Street Journal.

An FDA spokeswoman told the Journal that the Chinese plant "was supposed to be inspected" but was not due to "human error, and inadequate information-technology systems." The spokeswoman added that, "preparations are being made to perform an inspection as soon as possible," according to the report.

Both Baxter and the FDA said it wasn't clear that the product from the Chinese supplier is tied to the allergic reactions to the drug, heparin, which have resulted in four deaths, the report indicated.

Baxter (BAX, Fortune 500) said Monday that it was temporarily suspending production of heparin because of roughly 350 negative reactions that may be a result of the drug, mostly among patients undergoing kidney dialysis and heart surgery, the report said.