China’s drug regulator, the State Food and Drug Administration (SFDA), said in a statement that importing countries bear responsibility for inspecting facilities producing drugs for export, in line with international practice, the Wall Street Journal reported. The SFDA has been cooperating with the US Food and Drug Administration (FDA) on investigating a plant in Changzhou, Jiangsu province that produces the blood-thinner heparin for US drug firm Baxter International. The SFDA said the plant had been “verified” by the FDA in 2004, but the FDA said it did not inspect the facility due to a mix-up. It is unclear whether the Changzhou facility, which is majority-owned by Wisconsin-based US Scientific Protein, was the source of Baxter-produced heparin that was linked to four deaths in the US.
You must log in to post a comment.