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    Home > Medical News > Medical World News > Recall of 30000 pieces of instruments in flight inspection by State Food and Drug Administration

    Recall of 30000 pieces of instruments in flight inspection by State Food and Drug Administration

    • Last Update: 2019-11-27
    • Source: Internet
    • Author: User
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    ▍ finishing: Chocolate On November 25, the State Food and Drug Administration issued several notices indicating that Sichuan wowente Biotechnology Co., Ltd and Sichuan hualikang Medical Technology Co., Ltd recalled relevant devices respectively due to unqualified spot check by the State Food and drug administration According to the report of Sichuan hualikang Medical Technology Co., Ltd., the vacuum residue of the vacuum residue device on the sample under inspection is beyond the standard requirements of yy0339-2009 suction catheter for respiratory tract due to the unqualified product in 2019 Sichuan hualikang Medical Technology Co., Ltd conducted three-level recall of relevant products, involving 29870 products sold in China According to the report of Sichuan wowente Biotechnology Co., Ltd., the products involved fail to pass the national supervision sampling inspection in 2019, and the inspected items fail to meet the technical requirements of medical devices in gxzz 20162400011 glucose determination kit (glucose oxidase method) Sichuan wowente Biotechnology Co., Ltd carried out three-level recall of relevant products, involving 723 boxes of products sold in China On November 25, the State Food and Drug Administration issued the Circular of the State Food and Drug Administration on the suspension and rectification of Hainan Zhongsen Biotechnology Co., Ltd (No 84, 2019) Recently, the State Food and Drug Administration organized the flight inspection of Hainan Zhongsen Biotechnology Co., Ltd If it is found that the quality management system of the machinery enterprise has defects in equipment and production management, it shall be ordered to stop production immediately for rectification Within one month, this has been the fifth notice issued by the State Food and drug administration On November 7 and 12, the State Food and Drug Administration issued a circular respectively, in which two machinery enterprises in Hangzhou and Suzhou had defects in the quality management system after the flight inspection, and they stopped production for rectification; on November 13, the State Food and Drug Administration issued two more flight inspection notices, and two machinery enterprises in Shanghai and Taizhou, Zhejiang, stopped production for rectification It can be seen that the National Drug Administration's flight inspection efforts seem to be increasing.
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