Beijing, Nov. 1 (Xinhua)-National Medical Products Administration website reported that recently, National Medical Products Administration organized an off-site inspection of GlaxoSmithKline (Ireland) Limited, and the inspection variety was dutasteride soft capsules.
The inspection found that the enterprise did not carry out batch-by-batch and complete inspection of the products exported to China according to the registration standards, and there were shortcomings in the prevention and control of microbial pollution risks. The comprehensive evaluation concluded that the production quality management of this variety did not meet the requirements of good manufacturing practice (revised in 2010).
Image from National Medical Products Administration website
According to the relevant provisions of the Drug Administration Law of People’s Republic of China (PRC), National Medical Products Administration decided to suspend the import, sale and use of GlaxoSmithKline (Ireland) Limited dutasteride soft capsules from now on. The drug supervision and administration departments at the drug import ports shall suspend the issuance of import customs clearance forms for the above products. (Zhongxin Finance)
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