A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China's drug regulators to make pharmaceutical products, according to records and interviews.
Because the plant, Changzhou SPL, has no drug certification, China's drug agency did not inspect it. The U.S. Food and Drug Administration said this week it had not inspected the plant either - a violation of its own policy - before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.
Baxter announced Monday that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications. Why the heparin caused these problems - and whether the active ingredient in the drug, derived from pig intestines, was responsible - has not been determined.
The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that U.S. and Chinese health officials are attempting to close - in which chemical companies export pharmaceutical ingredients without a Chinese drug license.
China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration.
However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese agency's jurisdiction.
The heparin plant has not been accused of providing a harmful product. The U.S. majority owner of that plant, Scientific Protein Laboratories, also owns a plant in Wisconsin.