Thursday, February 14, 2008

China Plant Played Role

I am glad to see that the FDA will be inspecting this facility "soon"...

I was discussing this issue with a colleague the other day...we had noted that the vials produced at the plant had tested negative for contaimination and endotoxins...with that infromation, the person I was discussing this with said something alog the lines of "Mark my words, there will be an issue with one or some of the ingredients coming from oversees..."

A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday.

The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world.

Although it isn't known whether the Chinese plant played a part in the drug's problems, its role as a supplier to Baxter is expected to fuel questions about U.S. regulators' ability to ensure the safety and quality of imported drugs and drug ingredients.

On Monday, Baxter announced that it had temporarily halted production of its version of the generic anticlotting drug heparin because of about 350 bad reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery.

Yesterday, both Baxter and the FDA said it wasn't clear that the ingredient from the Chinese supplier was tied to the bad reactions. "We honestly don't know" the cause, an FDA spokeswoman said.

link to full article

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