China Esquire

Seems like reporting about Chinese products that cause injury and death are popular nowadays. As if my last posting regarding QC and Trader Joe’s banning certain Chinese products wasn’t enough, out comes a pair of articles from the New York Times and CNN Money.

Baxter International manufacturers a drug thinning blood called Heparin, which is commonly used for dialysis and heart surgery. Heparin has been linked to at least 4 deaths due to allergic reactions, on top of over 300 reported reactions to the product. And as you would suspect at this point, Heparin was manufactured in China. By a manufacturer that the U.S. Food and Drug Administration never inspected.

Ironically, there is a split in the fingerpointing. The Times places blame upon the Chinese manufacturer, questioning whether it was that manufacturer who is responsible for the spike in reported incidents. (And also mentions that its possible that the pigs used were Chinese… frankly speaking, I cannot imagine that is actually anything relevant and appears as a red herring to me)

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 F.D.A. spokeswoman, Heidi Robello, said 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. Ms. Robello said that she did not know whether the pigs used to produce the suspended product, made by Baxter International, came from China.

The quality of Chinese products became a source of concern last year after federal officials discovered that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died.

The CNN Money article, which I actually read first and was about to comment on before I noticed the New York Times one, places the blame on the FDA.

The active ingredient in a blood-thinning medication made by Baxter International Inc, which is being blamed for causing allergic reactions, was reportedly manufactured at a Chinese facility that was never inspected by the the U.S. Food and Drug Administration, according to a report in The Wall Street Journal.

An FDA spokeswoman told the Journal that the Chinese plant “was supposed to be inspected” but was not due to “human error, and inadequate information-technology systems.” The spokeswoman added that, “preparations are being made to perform an inspection as soon as possible,” according to the report.

Both Baxter and the FDA said it wasn’t clear that the product from the Chinese supplier is tied to the allergic reactions to the drug, heparin, which have resulted in four deaths, the report indicated.

Frankly, I pin the blame on both sides. Remember: due diligence and quality control will save you in doing business with China.

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