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七项一般缺陷 冠昊生物科技股份有限公司被勒令整改

2017-08-10 11:23:05   

中国网财经8月10日讯 日前,国家食药监总局发布通告称,在对冠昊生物科技股份有限公司进行飞行检查时发现,该企业存在查洁净车间的包材暂存间,传递窗(包材入口传递窗2F-03)与非洁净区相连,无指示压差的装置等7项一般缺陷。针对该公司检查中发现的问题,国家食药监总局要求广东食药监局责成企业限期整改,必要时跟踪复查,并要求企业评估产品安全风险,对有可能导致安全隐患的,应按照《医疗器械召回管理办法》的规定召回相关产品。企业完成整改后,广东省食药监局应将相关情况及时上报总局医疗器械监管司。

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