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Fda Tackles tainted drugs from China

机译:Fda Tackles污染了中国的毒品

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Following a series of high-profile scandals concerning tainted food and drugs imported from China, the U.S. Food and Drug Administration (FDA) announced in March that it would establish a drug-monitoring office in that country. The most alarming report involved contaminated batches of the blood thinner heparin, which caused at least three deaths and is under suspicion in dozens of others. In February FDA officials admitted that they had never inspected Changzhou SPL, the manufacturing plant in Changzhou, China, to which they traced the contaminated heparin. When the FDA eventually inspected the Changzhou SPL plant (in February), it found a host of quality-control and hygiene problems. Many drugs sold in the American marketplace are now imported, transforming what was once largely a domestic agency to one that must police products from more than 200 countries, notes Murray M. Lumpkin, FDA deputy commissioner for international and special programs. "The reality of globalization has hit the products for which we're responsible very, very significantly," he says. The pharmaceutical production process is also vastly more complex than it used to be. Individual ingredients are made in one place, put together in another, and bottled and labeled in yet other sites.
机译:在一系列有关从中国进口的受污染食品和药品的丑闻之后,美国食品药品监督管理局(FDA)于3月宣布,它将在该国建立一个药品监督办公室。最令人震惊的报告涉及受污染的血液稀释剂肝素批次,造成至少三人死亡,并怀疑数十人死亡。 FDA官员于2月承认,他们从未检查过常州SPL,这是中国常州的制造厂,他们在那儿找到了被污染的肝素。当FDA最终在2月对常州SPL工厂进行检查时,发现了许多质量控制和卫生问题。 FDA国际和特殊计划副专员Murray M. Lumpkin指出,现在在美国市场上出售的许多药物都是进口的,这使原本由国内机构转变为必须监管来自200多个国家/地区的产品的机构。他说:“全球化的现实已经非常非常重要地冲击了我们所负责的产品。”制药生产过程也比过去复杂得多。各个成分在一个地方制成,放在另一个地方,然后在其他地方装瓶并贴标签。

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