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FDA opens first office in China for inspections

U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.
/ Source: Reuters

U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.

The eight FDA workers in Beijing, Shanghai and Guangzhou will set up a process for pre-certifying and inspecting imports from China, which has hundreds of thousands of food processors and drug manufacturers.

A series of food safety scandals in China, where thousands of babies fell ill after melamine was introduced into milk formula to cheat protein tests, has triggered alarm in the United States, which imports about 15 percent of the food it consumes.

Problems with melamine-tainted dairy products from China were so pervasive that the United States issued an import alert, which force importers to certify that the food was problem-free before entering U.S. markets. A similar alert has been in effect on Chinese seafood since last year.

U.S. inspectors have complained in the past of limited access and information when investigating safety disputes with Chinese suppliers and manufacturers, but U.S. Secretary of Health Mike Leavitt said cooperation was improving.

Access was "clearly spelled out" in agreements between U.S. and Chinese authorities, Leavitt told reporters.

"Heparin, for example, was not one of the drugs under the agreement but those protocols were used and there were U.S. inspectors and Chinese inspectors together visiting the points of production," he said. "Progress is being made."

Chinese-made heparin, a blood thinner, was blamed for fatalities and adverse reactions in U.S. and German patients, prompting a recall by Baxter International Inc. early this year.

The FDA offices would try to identify and train laboratories that can certify shipments for faster clearance into the United States, with the goal of ultimately accepting inspections by Chinese quarantine and inspection agency AQSIQ.

China also plans to station food quality monitors in the United States, the China Daily said on Wednesday. China has on occasion blocked poultry imports from the U.S. as well as meat containing the growth hormone ractopamine, which is banned in China.

Weak regulation of chemical ingredients used in pharmaceuticals has also allowed manufacturers to sell counterfeit or faulty compounds that are later incorporated into drugs.

The FDA regularly inspects about 100 drug manufacturing facilities in India, which together with China is the main source for generic drugs, Leavitt said. He did not provide a comparable figure for China.

It would consider sharing information with inspectors from Japan, Europe, Canada or Australia, Leavitt said, to reduce the burden of monitoring the many manufacturers of generic drugs.

More on China food safety scandals  |  Food and Drug Administration