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US to investigate PRC source of drug that caused illness

A Chinese factory that has not been inspected by the Food and Drug Administration is the source for the active ingredient of a critical blood-thinning drug whose production was suspended this week after 350 patients reported ill effects from it.

At least four people died after being given the drug, heparin.

An FDA spokeswoman, Heidi Robello, said on Wednesday that the agency was making plans to inspect the Chinese factory as well as a finishing plant in New Jersey "as soon as possible."

She said that "it was yet to be determined" if the Chinese plant was the source of the problem that led to the spike in reports of problems with the drug's use.

Heparin is made from pig intestines. Robello said that she did not know whether the pigs used to produce the suspended product, made by Baxter International, came from China.

Heparin is used widely in dialysis, heart surgery and chronic care hospitals. Baxter manufactures half of the nation's supply of the drug, and the company's suspension of production of multiuse heparin vials is expected to lead to shortages.

Baxter spokeswoman Erin Gardiner said her company bought the active ingredient for the drug from another concern, which she would not identify. She said that company had plants in the US and China.

The Government Accountability Office recently reported that at its current inspection pace, the FDA would need at least 13 years to inspect every foreign drug plant that exports products to the US. The office, an independent arm of Congress, also found that the FDA's computer systems were deficient and it had little idea how many plants had been approved for exports to the US.
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