IHS Chemical Week

EnviroTech :: Regulatory

FDA Criticized for Negligence in Baxter Heparin Case

10:08 AM MST | March 3, 2008 | Deepti Ramesh

The U.S. FDA has been heavily criticized by Congress for not inspecting a plant in China that manufactures the active pharmaceutical ingredient (API) for heparin, a blood-thinning drug made by Baxter International (Deerfield, IL). Heparin has caused four deaths and had other harmful effects on a growing number of patients in the U.S. FDA confused the identity of the company that operates the Chinese API plant with that of another company with a similar name, when the API manufacturer applied for approval of its facility, reports say. The other company had been...

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