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FDA Issues Warning Letters To Two Chinese Producers Of Adulterated Heparin: Could Prosecution Lie Ahead?

This article was originally published in PharmAsia News

Executive Summary

BEIJING - In a move that could ultimately lead to civil or criminal prosecution, U.S. FDA has issued warning letters to two Chinese producers of raw heparin that was discovered to be contaminated with a look-alike chemical

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U.S.FDA established offices in China in 2008 to improve oversight of products exported to the U.S., and to establish stronger working relationships with China's State FDA. The mission of the office initially was to implement two agreements signed with China in December 2007 to enhance regulatory cooperation in the areas of food, drugs, medical devices and animal feed (PharmAsia News, Dec. 17, 2007). PharmAsia News' China and Australia bureaus spoke recently to FDA China Country Director Christopher Hickey about the mission of the China office and progress being made in China. This is part one of a two-part interview; please look for part two in an upcoming issue of PharmAsia News.

U.S. FDA China Country Head Chris Hickey On FDA's Mission In China: An Interview With PharmAsia News (Part 1 of 2)

U.S.FDA established offices in China in 2008 to improve oversight of products exported to the U.S., and to establish stronger working relationships with China's State FDA. The mission of the office initially was to implement two agreements signed with China in December 2007 to enhance regulatory cooperation in the areas of food, drugs, medical devices and animal feed (PharmAsia News, Dec. 17, 2007). PharmAsia News' China and Australia bureaus spoke recently to FDA China Country Director Christopher Hickey about the mission of the China office and progress being made in China. This is part one of a two-part interview; please look for part two in an upcoming issue of PharmAsia News.

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