Imports from China

Even so, the problems involving heparin have again focused attention on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. S.P.L.’s plant in Changzhou was certified by American officials to export to the United States even though neither government had inspected it. The plant has been exporting heparin to Baxter since 2004.
Like many chemical companies in China that make pharmaceutical ingredients for export, S.P.L. fell into a regulatory void. A spokesman for China’s State Food and Drug Administration, Shen Chen, said his agency had not inspected the S.P.L. factory because “as far as we know, it is not a drug manufacturer; it is a producer of chemical ingredients.” Mr. Shen said his agency was helping American investigators as part of a recent agreement with American regulators.