China Hinders FDA Inspection Plans by Delaying Visas

Source: PharmaManufacturing.com

Aug 20, 2013

pharmalive.com

An ongoing delay in obtaining visas from China for FDA staffers to work on a long-term basis in the country is preventing the agency from proceeding with plans to increase inspections, bolster regulatory practices and collaborate on public health strategies. 

The spokesman says the US State Department last October formally notified the Chinese Ministry of Foreign Affairs about obtaining visas for additional inspectors, a move made possible by an extra $10 million in FDA funding. The FDA wants to use the additional $10 million to increase the number of drug inspectors in China from just one to 11, and also employ nine food inspectors compared with two presently employed.

The agency has been waiting for the visas since January, but the FDA spokesman could not explain the hold up.

The delay is a setback to FDA efforts to improve the safety of the pharmaceutical supply chain, an issue that has been haunting the agency ever since contaminated heparin made in China was linked to 81 deaths in the US in 2007 and 2008. Read more
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