Heparin Case: China Says Responsibility For Quality Lies With Importing Nations
While claiming that it attaches high importance to quality standards, China has claimed it bears no responsibility in assuring quality for pharma products leaving its shores. As many as 400 illnesses and 21 deaths have been linked to tainted heparin produced in China. The FDA went to China only after the news of contamination broke, and the plant was said to be in sorry shape. The FDA has not been inspecting China plants often. Here are some numbers to think about…
“The inspection shortfall is particularly acute in China. The FDA has averaged just 15 inspections in China in each of the last five years. Yet China’s fast-growing industry now numbers 714 plants that ship drug products to the U.S. At that rate, it would take the agency nearly 48 years to inspect each plant just once — and well more than that, if China’s booming 17 percent annual growth rate for drug exports is taken into account.”
It is worrisome that China insists it bears no responsibility. China certainly wishes to assure high quality standards for the products that are produced in its country. It is in its best interest to export only quality goods - regardless of who owns the factory. When China says that it cannot guarantee quality, maybe it means that it is incapable. Question: If China can’t get the job done from home, how successful can we expect the FDA to be in doing the job from afar?