Article - April 30, 2008 - RedOrbit

Heparin Plant in China Passed 'in-Depth' Review

By Julie Schmit

The Chinese plant that supplied contaminated heparin to the USA passed an audit by Baxter International just months before Baxter started recalling the blood thinner, according to testimony at a congressional hearing Tuesday.

Contaminated heparin has been associated with 81 deaths in the USA and has been found in 11 countries.

The Baxter audit in September -- considered an "in-depth" review although it took just one day -- raises questions about Baxter's due diligence and the government's reliance on industry to largely police itself, said David Nelson, an investigator for the House subcommittee investigating the contamination of heparin.

"At best, (the audit) was an incomplete, bordering on failure," Nelson testified.

A Food and Drug Administration inspection five months later, after Baxter had begun its recall, found the plant to be inadequate. The FDA said the plant did not adequately check suppliers and lacked the ability to remove impurities from heparin, among other criticisms.

Baxter CEO Robert Parkinson testified that the Baxter audit was "routine," while the FDA's was an "inspection for cause."

He said Baxter is re-examining its global supply chain and that less than 1% of its products sold in the USA include components sourced in China.

Heparin, which is derived from pig intestines, is used in surgeries and dialysis to prevent blood clots.

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