Heparin plant in China passed 'in-depth' review
USA TODAY, April, 2008 by Julie Schmit
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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.
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"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 ...
