Friday, the Food and Drug Administration announced new testing requirements for all imported Heparin. Manufacturers must agree in advance to undertake sophisticated tests or their shipments will be held at ports of entry for government testing.
There is conjecture that the raw ingredient was contaminated even before reaching the Changzou plant, in the pig farm supply chain.
Heparin is derived from the lining of pig intestines. The contamination is by a look-alike ingredient.
The FDA is widening its investigation of hundreds of allergic reactions linked to Baxter International's Heparin.
Heparin is the same blood thinner with which Dennis Quaid's newborn twins were accidentally overdosed.
Contaminants were found in 20 of 28 samples.
Pending Chinese government approval, the FDA will be installing eight full-time regulators at U.S. diplomatic posts in China as “a significant step toward ensuring access to safe food, drugs and medical devices in the global market.”
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