Chinese Plant at Fault?

The active pharmaceutical ingredient in the contaminated heparin was produced by Scientific Protein Laboratories in two different locations: Waunakee, Wisconsin and Changzhou, China. The active pharmaceutical ingredient (API) in heparin has been produced in SPL’s Chinese plant since 2004. 

Until the recent investigation, the FDA had never inspected SPL’s Chinese facility, an oversight for which they have been heavily criticized.  The Chinese plant was also never certified by China’s drug regulators to make pharmaceutical products, which means it was never inspected by Chinese authorities.  The FDA did eventually inspect the Chinese facility finding several deficiencies in the plant's manufacturing of heparin.

The key active ingredient in heparin is made from an enzyme found in the mucous lining of pig intestines.  At first, there were concerns of an accidental contamination since China, a large producer of pigs and the foremost producer of the enzyme used in heparin, had been plagued by pig disease this past year. Most pig farms in rural China are unregulated and family owned.

After an investigation into the adverse reactions to heparin, a contaminant mimicking heparin’s key ingredient was discovered called over-sulfated chondroitin sulfate.  This chemical could never occur naturally, prompting many experts to believe it purposefully added.  Officials have pointed a finger at the Chinese plant, identifying it as the possible source for the contaminated heparin. Both the FDA and Baxter believe that the deadly contaminant was introduced during production in China.

On April 21, 2008, the FDA sent a letter the to Changzhou SPL warning them that until the facility ensured the raw materials they use are safe by implementing adequate inspection systems,  no US company would use it as a manufacturer.

In the letter, the FDA reprimanded the Chinese plant saying it had “significant deviations” from current good manufacturing practices.

Chinese officials disagreed with both the FDA and Baxter, telling reporters that the contaminant could have possibly been introduced in Baxter’s refining and distribution plant in New Jersey.  FDA officials though, insist that evidence and data links the origin of the contamination to China.

The countries of Australia, Denmark, France, Germany, Italy, Japan and Switzerland have also recalled lots of heparin pending investigations into the Chinese plant.

Additional Articles:

Chicago Tribune: Baxter calls tainting 'deliberate'
Pharmalot.com: Chinese Heparin Plant Was Never Licensed
Chicago Tribune: Heparin Timeline

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