More on the heparin problem--guess what, it leads to China....
According to the February 16 New York Times, the Chinese company that supplies much of the active ingredient for a brand of blood thinner that has been linked to four deaths in the U.S., was never certified by China's drug regulators to make pharmaceutical products.
The company, Changzhou SPL has no pharmaceutical license and is not inspected by Chinese authorities. Its majority owner is an American company, Scientific Protein Laboratories. The Company also has a plant in Wisconsin: no one has confirmed which plant provided the tainted heparin.
There are literally thousands of unregulated chemical companies in China who produce ingredients of pharmaceuticals. In December, Chinese and American regulators signed a deal under which China would begin registering some of these companies. Some of the companies have been linked to counterfeit, diluted or simply contaminated drugs, including the tainted drug that poisoned more than 170 people in Panama, killing 115.
The US Food and Drug Administration claims that this plant was not inspected because of a "glitch" in the system. Next time the government questions your tax return, trying justifying it as a "glitch" in your system and see how that works out. The FDA inspects only 10 or 20 of the 700 approved Chinese drug plants, and apparently very few of the non-approved "chemical" plants.
In the meantime, the potentially tainted heparin is not being pulled from the market as it would likely create a shortage of heparin. Instead, doctors are being provided with guidelines that stress using less heparin and administering it with steroids or antihistamines to minimize risk.