FDA DESCRIBES ON-GOING INSPECTION AND ANALYTICAL CAPABILITIES
“Our primary duties have been to build relationships with FDA’s regulatory counterparts and to work with Chinese firms that want to export products to the United States,” states Christopher Hickey, Ph.D. who leads the FDA’s 13-person staff in China.
The office also aims to increase the number of inspections at manufacturing plants; boost collaboration on product safety with other U.S. government agencies; and monitor events—like an earthquake or other natural disaster—that could affect the safety or availability of FDA-regulated products.
And the team may be getting reinforcements. In his budget proposal for the 2013 fiscal year, President Obama has requested funding that will enable FDA to:
- strengthen its inspection and analytical capabilities by increasing its presence in China by sixteen inspectors and by adding three U.S.-based China analysts.
- broaden the range of its inspections. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will inspect sites of clinical trials and conduct follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions, and that they apply sound production practices.
Please visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284461.htm to learn more.
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