{"id":2105,"date":"2016-08-29T09:46:37","date_gmt":"2016-08-29T09:46:37","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=2105"},"modified":"2016-08-29T09:46:37","modified_gmt":"2016-08-29T09:46:37","slug":"zhejiang-pharma-got-warning-from-fda-which-might-affect-the-market-exploitation-in-the-us","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2016\/08\/29\/zhejiang-pharma-got-warning-from-fda-which-might-affect-the-market-exploitation-in-the-us\/","title":{"rendered":"Zhejiang Pharma got warning from FDA, which might affect the market exploitation in the US"},"content":{"rendered":"<p style=\"text-align: justify\"><strong>On 11<sup>th<\/sup> August, Zhejiang Pharma, which is the biggest Vitamin E manufacturer, announced that the subordinate company \u2013 Xinchang Pharmaceutical factory \u2013 got a warning letter from U.S. Food and Drug Administration. From the on-site inspection, FDA found three defects which did not meet the requirements of cGMP. The factory is ordered to make rectifications. Many experts from the industry worry that the warning might affect its market exploitation in the US. (Source: Pharmnet)<\/strong><\/p>\n<h3 style=\"text-align: justify\">\u6d59\u6c5f\u533b\u836f\u5b50\u516c\u53f8\u906dFDA\u8b66\u544a \u6050\u6ce2\u53ca\u7f8e\u56fd\u5e02\u573a\u5f00\u62d3<\/h3>\n<p style=\"text-align: justify\">\u6765\u6e90\uff1a<a href=\"http:\/\/www.menet.com.cn\/info\/201608\/201608220932163216_131942.shtml\" target=\"_blank\">\u533b\u836f\u7f51<\/a> 2016-08-22<\/p>\n<p style=\"text-align: justify\">\u6838\u5fc3\u63d0\u793a\uff1a8\u670811\u65e5\uff0c\u56fd\u5185\u7ef4\u751f\u7d20E\u4ea7\u91cf\u6700\u5927\u7684\u6d59\u6c5f\u533b\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8\u53d1\u516c\u544a\u79f0\uff0c\u516c\u53f8\u4e0b\u5c5e\u4f01\u4e1a\u65b0\u660c\u5236\u836f\u5382\u6536\u5230\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d1\u51fa\u7684\u8b66\u544a\u4fe1\u3002FDA\u73b0\u573a\u68c0\u67e5\u53d1\u73b0\uff0c\u65b0\u660c\u5236\u836f\u5382\u5904\u7f6e\u4e0d\u7b26\u5408cGMP\u89c4\u5b9a\u7684\u4e09\u6761\u7f3a\u9677\uff0c\u5e76\u8d23\u4ee4\u6574\u6539\u3002\u6d59\u6c5f\u533b\u836f\u6b63\u6839\u636e\u8981\u6c42\u6574\u6539\u3002\u591a\u4f4d\u4e1a\u5185\u4eba\u58eb\u62c5\u5fe7\uff0c\u6d59\u6c5f\u533b\u836f\u5b50\u516c\u53f8\u906dFDA\u8b66\u544a\u6050\u6ce2\u53ca\u5176\u7f8e\u56fd\u5e02\u573a\u7684\u5f00\u62d3\u3002<\/p>\n<p style=\"text-align: justify\">\n<p>[hide for= &#8220;!logged&#8221;]<\/p>\n<p style=\"text-align: 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justify\">\u76ee\u524d\uff0c\u6d59\u6c5f\u533b\u836f\u5c1a\u672a\u62ab\u9732\u6574\u6539\u8fdb\u5c55\uff0cFDA\u4e5f\u5c1a\u672a\u4f5c\u51fa\u76f8\u5173\u4ea7\u54c1\u80fd\u5426\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u7684\u8fdb\u4e00\u6b65\u63aa\u65bd\uff0c\u7531\u6b64\u5e26\u6765\u7684\u8fdb\u4e00\u6b65\u5f71\u54cd\u5c1a\u4e0d\u5f97\u800c\u77e5\u3002<\/p>\n<p>[\/hide]<\/p>\n<p style=\"text-align: justify\">\n","protected":false},"excerpt":{"rendered":"<p>On 11th August, Zhejiang Pharma, which is the biggest Vitamin E manufacturer, announced that the subordinate company \u2013 Xinchang Pharmaceutical factory \u2013 got a warning letter from U.S. Food and 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