The Wall Street Journal reported Wednesday that the FDA never inspected a facility in China that manufactured the active ingredient in Baxter's anticoagulant, heparin. The drug is under investigation by the US agency after it received hundreds of reports of severe allergic reactions and four deaths in patients who took the product.

An FDA spokesperson stated that the Chinese facility was "supposed to be inspected" but that as a result of "human error and inadequate information technology systems," it was not inspected. The spokesperson added that the agency plans to inspect the plant as soon as possible.

According to the report, both the FDA and Baxter specified that it is not clear the allergic reactions are linked to the product from the Chinese facility. Earlier this week, Baxter said it would suspend production of multi-dose vials of heparin as it would try to determine the cause of the increase in adverse reactions.

Reference Articles

Chinese maker of heparin ingredient wasn't inspected by US - (Bloomberg)

FDA never inspected plant tied to defective drug - (CNN Money)

Baxter heparin ingredient made in uninspected plant: report - (MarketWatch)

FDA never inspected Chinese facililty where ingredient in heparin is made (free preview) - (The Wall Street Journal)