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<p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">国家药监总局针对医疗器械经营企业的飞行检查还没展开，地方药监局却早已经行动了。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">南昌市药监局于2016年8月10日至12日对辖区内36家医疗器械经营企业进行了飞行检查。该飞检是根据《关于印发南昌市整治医疗器械流通领域经营行为工作方案的通知》（洪食药监字〔2016〕130号）等的要求而展开的，也即归属械商大整治的一部分。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">飞检对象为25家经营冷藏冷冻产品的经营企业和11家其他类型的医疗器械经营企业，由南昌市药监局在各监管单位遴选了20名执法人员，组成10个飞检组，采取异地交流检查的方式组织实施。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">重点飞检内容有4项：经营条件是否与许可审批时一致；需要冷藏、冷冻医疗器械的冷链管理是否符合规定；查验产品是否从正规渠道购进；是否存有销售无注册证、超过有效期产品的现象等。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">对这36家企业的飞检结果如下：</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">1、有1家之前就已经注销了。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><table cellspacing="0" cellpadding="0" width="670"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" nowrap="" height="19" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">被检企业</span></p></td><td width="331" nowrap="" height="19" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">主要问题</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西泰来医疗器械有限公司</span></p></td><td width="331" nowrap="" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">东湖区市场和质量监督管理局已于2016年7月注销</span></p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 25.6px; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">2、有7家质检员没能进入现场实施飞行检查，原因几乎都是，企业相关人员在外出差...</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><table cellspacing="0" cellpadding="0" width="670"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; height: 19px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="19" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">被检企业</span></p></td><td width="331" height="19" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">主要问题</span></p></td></tr><tr style="max-width: 100%; height: 56px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌巴通贸易有限公司</span></p></td><td width="331" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质检员来到检查现场，因无钥匙无法进入企业经营场所，与企业负责人联系，称仓库管理员在外出差，无法到达现场。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌龙创医疗器械有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场大门紧闭，无人办公，与企业负责人联系，称工作人员均在外出差，无法到达现场。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西晟康医疗器械有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场大门紧闭，无人办公，与企业负责人联系，称工作人员均在外出差，无法到达现场。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西俊航实业有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">企业法定代表人称在外旅游，当地无公司人员在场，故无法进入该公司，检查就此终结。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西嘉航医疗器械有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量负责人在外地出差，不在检查现场。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西博一科技有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场大门紧闭，无人办公，经联系其公司工作人员均在外出差，无法到达现场。</span></p></td></tr><tr style="max-width: 100%; height: 56px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市新达医学检验耗材有限公司</span></p></td><td width="331" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">联系相关人员到达不了现场；2.原核准场所之一据邻居反映为私人住房，并非公司。</span></p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">3、有27家被检查出存在各种各样、或多或少的问题。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><table cellspacing="0" cellpadding="0" width="670"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; height: 25px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="25" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">被检企业</span></strong></p></td><td width="331" height="25" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">主要问题</span></strong></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌汇雄科技有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场随机抽查的产品未记录到货温度。</span></p></td></tr><tr style="max-width: 100%; height: 149px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西益成实业有限公司</span></p></td><td width="331" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">验收员与质检员未能同时在岗；2.冷藏车、冷库、保温箱的验证不规范，没有验证方案和验证报告；3.阴凉库温湿度计不能正常使用，调取冷库的温湿度监测记录未采集湿度；4.抽查的产品未确认到货温度，未留存来货产品的运输过程温度记录；企业未按2016年度培训计划开展培训并考核；5.医疗器械质量管理软件不能生成采购单，不能实现近效期预警。</span></p></td></tr><tr style="max-width: 100%; height: 168px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="168" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西华维科技发展有限责任公司</span></p></td><td width="331" height="168" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理体系文件（制度）不能满足现行法规要求；2.质量负责人对医疗器械质量管理要求和执行程序不熟悉，无履职记录；3.冷库未设置预冷区及待发货区，冰箱未配备温湿度监测设备且监测记录不全；4.仓库五防设施不足，无在库产品的养护记录；5. 未对委托物流运输企业进行评估；6.未建立冷藏产品运输记录；7.首营企业、首营品种未做审核；8. 未明确工作人员负责医疗器械不良事件监测工作，且未注册医疗器械不良事件监测平台。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市安达检验科技有限公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理体系文件（制度）不能满足现行法规要求；2. 冷库无备用制冷机组，阴凉库温湿度调控设备不能满足实际需要；3.未留存销售人员的法人委托书及身份证复印件。</span></p></td></tr><tr style="max-width: 100%; height: 243px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="243" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西天豪仪器设备有限公司</span></p></td><td width="331" height="243" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理体系文件（制度）不能满足现行法规要求；2.质量负责人对医疗器械质量管理要求和执行程序不熟悉，无履职记录；3.部分阴凉柜不能正常运行，冷库报警系统不能正常运行，无备用制冷机组，冷库不能实现自动监测和记录，冷库未设置预冷区及待发货区；4.仓库无温湿度监测记录，未设置分区标识，未配全五防设施，无在库产品的养护记录，医疗器械产品与非医疗器械产品混存混放；5.未对委托物流运输企业进行评估，未签订委托运输质量保证协议；6.冷链产品无在途温度记录，保温箱未验证，计量器具未检定或校准；7.未留存业务员的法人委托书、身份证复印件；8. 未及时注册医疗器械不良事件监测平台。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西百康实业有限公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.2016</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">年8月1日冷库1至4号监测点的温湿度记录不完整;2.医疗器械产品与非医疗器械产品混存混放；3.未指定专人负责医疗器械不良事件监测工作。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌华安医检科技有限责任公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1. </span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">冷库温度超标时，质管人员未收到报警信息；2.2016年8月7日冷库1号温测点超标未及时采取处理措施；3.阴凉库的温湿度计未能及时检定；4.库房未完全密闭。</span></p></td></tr><tr style="max-width: 100%; height: 168px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="168" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市云意科技有限公司</span></p></td><td width="331" height="168" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">冷库的温湿度监测系统不能正常监测温湿度，温度超标时，质管人员未收到报警信息；2.不能提供抽查产品的相关资质证明性文件；3.库房无五防设施，未设置待验区、合格品区、退货区等；4.医疗器械质量管理软件未根据岗位设定相应权限；5.冷链产品未记录到货温度，未索取留存在途温度记录，没有配备温度监控设施；6.未承担医疗器械不良事件报告工作；7.质量管理体系文件（制度）不能满足现行法规要求。</span></p></td></tr><tr style="max-width: 100%; height: 131px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="131" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西佳和医学设备有限公司</span></p></td><td width="331" height="131" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">常温库货架不足，防虫设施不符合要求；2.冷链管理制度及规程未按《医疗器械经营管理规范》等的要求及时更新改版；3. 随货同行单的内容不全，缺生产企业及储运条件等信息，部分留存了在途温度记录；4. 购置了医疗器械质量管理软件，但软件功能不能满足《医疗器械经营管理规范》的要求。</span></p></td></tr><tr style="max-width: 100%; height: 56px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西匡国实业有限公司</span></p></td><td width="331" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">三楼经营场所和五楼库房已撤销；2.无仓储设施设备；3.质量管理人员不在职在岗；4.没有医疗器械质量管理软件。</span></p></td></tr><tr style="max-width: 100%; height: 317px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="317" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市源德锦程生物技术有限公司</span></p></td><td width="331" height="317" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量负责人和质检员不在场，无2016年度培训、体检记录；2.B161室阴凉库货架不足、无五防设施，冷库报警功能不能正常使用，未见备用发电机组，冷库、保温箱未验证，冷藏车正在维修，无其础设施设备的定期检查、清洁和维护记录；3.现场仅提供2008年4月制订的体外诊断试剂管理制度和程序，未制定其它的质量管理体系文件，冷链管理制度及规程未按《医疗器械经营管理规范》等的要求及时更新改版；4.随货同行单的内容不全，缺生产企业及储运条件等信息，未留存在途温度记录；5.未能提供购进产品的采购合同、质量保证协议和售后服务协议，未见上述产品的验收、养护和销售记录，未能提供销售人员的授权存根；6.无计量器具的使用及检定记录;7.购置了医疗器械质量管理软件,但未使用软件进行进销存管理;7.售后服务操作规程和制度未更新,未及时注册医疗器械不良事件监测平台。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西东海医药有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理员未按时进行体检；2.库房有电线裸露，未配备防鼠、防蝇设施。</span></p></td></tr><tr style="max-width: 100%; height: 56px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌众越科技有限公司</span></p></td><td width="331" height="56" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">库房和阴凉库的温控设施不能正能运行；2.首营企业审核表和产品验收记录未签名；冷链运输与保温监测记录未建档保存。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西福田医疗科技有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">未与主要供应商签订质量保证协议；2.未收集销售人员的授权委托书和身份证复印件。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西鑫韩医疗设备有限公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场未见质量管理员；2.企业法定代表人陈述自取证以来未从事医疗器械经营活动，故无相关资料和记录；3.计算机未开启，未见医疗器械质量管理软件。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市辉辰医疗器械有限公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场未见质量管理员；2.库房无货架、无防鼠、防蝇设施；3.企业法定代表人陈述自取证以来未从事医疗器械经营活动，故无相关资料和记录；4.未使用医疗器械质量管理软件。</span></p></td></tr><tr style="max-width: 100%; height: 75px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西硕顺商贸有限公司</span></p></td><td width="331" height="75" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1. </span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理人检查时未在现场；2.企业法定代表人陈述自取证以来未从事医疗器械经营活动，故无相关资料和记录；3.库房无避光、防鼠设施；4.未使用医疗器械质量管理软件。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西江泓实业有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理人检查时未在现场；2.未建立进货台帐和销售记录；3.未见冷链运输记录。</span></p></td></tr><tr style="max-width: 100%; height: 112px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="112" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西辉跃医疗器械商贸有限公司</span></p></td><td width="331" height="112" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量管理人员均不在职在岗，电话联系质量负责人称其已于去年离职，电话联系质检员称其不是本人；2.没有安装医疗器械质量管理软件；3.企业不能提供劳动合同、健康档案、培训档案及质量管理制度（文件）；4.冷库及冷藏车现场开机3小时不能降温，备用发电机组未与冷库连接。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西鑫宇医疗器械有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">擅自设立了冷库，现场能正常运转；2.四楼库房的温控设施已损坏。</span></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西易佰贸易有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">直接接触医疗器械产品的员工没有每年进行健康检查；2.库房无避光设施。</span></p></td></tr><tr style="max-width: 100%; height: 93px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="93" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市晓庆医疗器械有限公司</span></p></td><td width="331" height="93" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">直接接触医疗器械产品的员工没有每年进行健康检查；2.库房没有配备与经营规模相适应的设施设备，如货架、托盘，没有实行分区管理；3、医疗器械贮存作业区和辅助作业区没有隔离措施。4.企业未对在库产品进行定期检查并保留相关记录。</span></p></td></tr><tr style="max-width: 100%; height: 187px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="187" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西省盈科科技有限公司</span></p></td><td width="331" height="187" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">未见法定代表人和企业负责人的2016年体检报告和培训考核记录；2.质量负责人和质检员不在检查现场，提供今年5月份工资发放表上没有上述人员的工资发放记录，未与质量负责人签订2016年劳动合同。3.部分保温箱未提供验证报告；4.没有留存物流单据；5.未指定员工负责医疗器械不良事件监测和报告工作；5.首营企业和首营品种档案内容不全；6.抽查的产品在医疗器械质量管理软件中没有销售出库和验收记录，软件无近效期预警功能；7.验收和销售记录不全。</span></p></td></tr><tr style="max-width: 100%; height: 93px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="93" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西省瑞拓实业有限公司</span></p></td><td width="331" height="93" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">质量负责人的体检报告中缺少胸透检查项目，无2016年的培训记录；2.没有填写冷链运输交接单；3.首营企业和首营品种档案不全；4. 安装了医疗器械质量管理软件,但未使用软件进行进销存管理;5. 无在库产品的养护记录。</span></p></td></tr><tr style="max-width: 100%; height: 187px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="187" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">南昌市贝雅特科技有限公司</span></p></td><td width="331" height="187" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">部分员工现场未提供2016年度体检报告；2.冷冻冰箱没有温湿度记录，保温箱现场不能提供验证报告；3.留存了供方的冷链运输记录，但没有填写到达时间、到达温度、运输方式等项目，没有留存在途温度记录；4.抽查的产品的出库单没有产品编号、生产日期等项目，销售出库单没有注册证号，生产企业名称、供应商名称等项目；5.未填写首营品种审核表；6. 医疗器械质量管理软件中购销记录不完整，部分产品未录入；7.未指定员工负责医疗器械不良事件监测和报告工作。</span></p></td></tr><tr style="max-width: 100%; height: 149px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西荣润商贸有限公司</span></p></td><td width="331" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">现场未见质量管理人员，无法提供工资发放记录；2.阴凉库内摆放了按摩椅等与经营无关的物品；3.现场无法提供冷链运输记录和相应产品的购进凭证及随货同行单、发票等；4.未制定温湿度监测设备检测制度，未开展检定检测工作；5.冷藏箱因运输原因摔坏已无法使用，已丢弃；未安装医疗器械质量管理软件；6.企业暂未按照国家有关规定承担医疗器械不良事件监测和报告工作。</span></p></td></tr><tr style="max-width: 100%; height: 149px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西众乐贸易有限公司</span></p></td><td width="331" height="149" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">仓库已于2016年6月底退租，未再使用，也无法打开仓库；2.质量管理人员无法提供工资发放记录等；3.未提供冷链运输记录及相应产品的购进凭证；4.抽查的产品未提供随货同行单，未提供销售出库单；4.未对计量器具开展检定检测工作；5. 安装了医疗器械质量管理软件，但营业以来未使用；6. 企业暂未按照国家有关规定承担医疗器械不良事件监测和报告工作。</span></p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">4<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">、还有1家企业，这是检查了呢？还是没检查？</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><table cellspacing="0" cellpadding="0" width="670"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; height: 25px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="25" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">被检企业</span></strong></p></td><td width="331" height="25" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(221, 235, 247);"><p style="max-width: 100%; min-height: 1em; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">主要问题</span></strong></p></td></tr><tr style="max-width: 100%; height: 37px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="99" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">江西美泰科技有限公司</span></p></td><td width="331" height="37" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(226, 239, 218);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">1.</span><span style="max-width: 100%; font-size: 15px; font-family: 宋体; color: rgb(51, 51, 51); box-sizing: border-box !important; word-wrap: break-word !important;">检查现场未发现该企业门牌及办公痕迹；2.原核准的注册地址上有其它单位正在使用。</span></p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">归结起来，南昌市药监局经过飞检后发现，该市械商主要存在以下6方面的不依法经营或者不符合医械GSP要求问题：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">1、企业核准的注册经营地址大门紧闭，人去楼空，通知企业相关人员也未到现场。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2、擅自改变原许可审批的经营条件。企业擅自变更经营地址和仓库地址；公司注册经营地址改作他用，已不具备医疗器械经 营条件。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">3、质量负责人不在岗。检查发现企业质量负责人不在岗问题比较突出， 无人履行质量管理职责。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">4、需低温冷链管理的医疗器械管理不规范等问题。少数体外诊断试剂经营企业冷链设施设备不能满足储运要求，冷链设施设备不能正常运转，冷库和保温箱等未经验证，企业没有留存在途温度等。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">5、库房管理不规范。缺少“五防”设施，温控设施不能正常使用，未进行分区分类管理等。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">6、购销记录内容不完整。个别企业未建立购进、销售记录；未使用计算机管理系统，无法做到产品可追溯。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对在飞检中发现的问题，南昌市药监局要求必须责令企业限期整改，实施跟踪检查，督促企业整改到位；对整改不到位的，要及时采取措施；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对未能实施飞检的企业，由所在地监管部门依据《医疗器械经营质量管理规范》等进行全项目检查；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对该注销的企业给注销；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对存在违法违规行为的企业，及时立案查处。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">南昌市药监局在飞检中发现的六大主要问题，其实在各地针对医疗器械经营企业的检查中也是频频出现的。据悉，像云南省昆明市药监局、湖南张家界市药监局等，也早已部署要针对械商展开飞行检查。国家局的飞行检查也将于10月正式启动。南昌局的先行检查如何进行，可供械商们作为参照。</p><p><br /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 邮编：510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电话：(+86)020-8722 8723 8764 5360 8764 2943 传真：020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">全国统一免费服务热线：400-020-6788</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众帐号：</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;" /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询：QQ: 712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">设备咨询: QQ: 712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">交流Q群：1106 11074</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">网址：http://www.yiliaoshebeiweixiu.com</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br /></span></p><p><br /></p>
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发表于 2020-10-19 23:48:05