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Non-compliant Chinese manufacturers continue to be under FDA scanner

US FDA has issued import alert to three more Chinese Pharmaceutical companies for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. According to FDA, drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) were subject to DWPE [Detention Without Physical Examination] for companies like, Xinxiang Pharmaceutical Co. and Xinxiang Tuoxin Biochemical Co. Both companies received FDA Form 483s in 2015. Another company recently added to import alert list was Guangzhou Haishi Biological Technology Co.

Currently 44 Chinese companies are under FDA import alert list whose products are banned from entering the US. According to FDA dashboard, Between FY 2009 and FY 2015, FDA conducted 1,389 inspections in China, though only 468 of those were conducted by FDA's Center for Drug Evaluation and Research, and of those 468, only 23 inspection reports called on the companies to take official action.

FDA has issued eight warning letters to the below mentioned Chinese pharmaceutical and API companies since 2014:


• Beijing Shunxin Meihua Bio-technical Co.
• China Resources Sanjiu Medical and Pharmaceutical Co.
• Novacyl Wuxi Pharmaceutical Co. Ltd.
• Zhejiang Jiuzhou Pharmaceutical Co.
• Tianjin Zhongan Pharmaceutical Co., Ltd.
• Yunnan Hande Bio-Tech. Co. Ltd.
• Wuxi Kaili Pharmaceuticals Co., Ltd.
• Zhejiang Hisun Pharmaceutical Co.


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