Chagzhou Scientific Protein Laboratories, which own the factory that supplies Baxter's blood thinner, heparin, was never checked by drug regulators in China. The plant has no certification. Heparin has led to four recent deaths in the USA, as well as hundreds of allergic reactions throughout the country.
In fact, Dr. Murray Lumpkin, Deputy Commissioner for International Programs, FDA, says the Chinese authorities do not routinely inspect drug plants that make medications purely for exports to the USA. Chinese made drugs have been suspected of having caused serious adverse events and even death in some parts of the globe.
The US Food and Drug Administration (FDA) had not ordered a total recall of the shipped drug as it was feared this might provoke a serious national shortage. The Agency has suggested that health care professionals give their patients steroids or antihistamines in combination with heparin to prevent allergic reactions.
Baxter supplies half of the total US demand for heparin, a blood thinning drug made from pig intestines.
The Chinese factory, owned by Scientific Protein Laboratories, located outside Shanghai, produces and supplies the active ingredient for Baxter's heparin. The active ingredient is derived from an enzyme in pig intestines. Baxter processes, sterilizes and packages the finished product for distribution in the USA.
According to Lumpkin, Chinese drug regulatory authorities only inspect plants that manufacture medications for domestic sales. Although some plants that produce just for export are inspected, their inspections are not mandatory.
David Trunce, CEO, Scientific Protein Laboratories, said that their company cannot force Chinese authorities to come and inspect their plant. The company says it moved production to China three years ago because the country is the world's largest supplier of pigs.
Since December, 2007, US FDA and Chinese authorities (SFDA) have been working towards achieving better quality control procedures for drugs produced in China for the US market. Lumpkin said the FDA and SFDA have been working to develop a system whereby standards are met.
The US FDA would like to be able to make unannounced inspections of Chinese plants that supply the US market - surprise inspections. At present US FDA inspections in China are not surprise visits - the plant knows well in advance.
In 2007 the head of China's SFDA was executed for corruption - he was accused and convicted for taking backhanders (bribes) to approve drugs.
China has become the world's number one supplier of pharmaceutical active ingredients. As the country becomes more dominant in the supply of active ingredients to Western Europe, North America, and Japan, there is growing concern that regulatory standards have not kept up with this explosion in business. China has also entered a market which to date has been India's domain - the production of generic drugs.