又有16家械企遭飞检，主要问题一览

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                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">日前，江西省药监局通报，该局组织对省内16家医疗器械生产企业实施了飞行检查。通报称，飞检是为了分析查找医疗器械产品监督抽验不合格原因，所以这算是一次集中、有针对性的有因飞检。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br  /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvdTXRxF2w0OMKPUnAZ6cUQDbBSZAYyqmnujBSZOwMrEH5gJxbmf5IokdE1t7KicQVru5MWSo1iaRBaA/0?wx_fmt=jpeg" data-ratio="0.5238095238095238" data-w="420"  /></p><p style="text-align:center"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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;">现场检查发现，</strong><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">有3家企业存在严重缺陷，主要问题分别如下：</strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">1、江西上高县锋兴医疗用品厂：真空采血管关键生产设备真空箱压力表未检定，抽真空工艺参数未验证；未制定进货、出厂检验和抗凝剂添加规程；200型离子交换纯水器、NC101-2型电热恒温干燥箱不能正常运行；缺添加剂含量检测设备原子荧光分光光度计。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2、昌市康洁医用卫生用品有限公司：检查现场正在生产的一次性使用无菌阴道扩张器部件无生产记录、投料记录和生产流转卡；未制定抗变形能力和结构强度测定仪操作规程；托盘式电光分析天平精度达不到要求，且无法正常使用。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">3、江西特力麻醉呼吸设备有限公司：整机装配流转卡中未记录各电路板批号，无法满足可追溯要求；管理者代表不在岗。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; 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;">检查还发现了各企业存在的一些共性问题，</strong>包括：<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">未与供应商签订质量协议；未对不合格品进行处置；未对不合格原因开展深入分析；进货、出厂检验能力不足；未按规定留样；净化车间传递窗不能正常使用，安全门未密封；无工艺用水储罐和管道清洗消毒记录等。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; 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; box-sizing: border-box !important; word-wrap: break-word !important;">江西省药监局责成对3家存在严重缺陷企业开展跟踪检查，并督促企业整改到位，处理情况及时报省局。对其他13家生产企业，企业所在地监管部门也要督促及时整改。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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; box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvdTXRxF2w0OMKPUnAZ6cUQDSDD7kWoE3n3IxbcFvle9MgE2I5tOunsutibjwmPJIs4t3gfM5Tjj48g/0?wx_fmt=jpeg" data-ratio="0.75" data-w="400"  /><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">此外，在现场检查时，16家企业中有7家处于停产状态。分别如下：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">1.江西特力麻醉呼吸设备有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2.江西格朗生物技术有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">3.南昌市康圣医疗器械有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">4.南昌卫材医疗器械有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">5.南昌裕华医疗器械有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">6.南昌益民医用卫生材料有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">7.江西松鹤医疗器械有限公司</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; 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); font-size: 16px; line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">通报要求，对上述飞检时处于停产状态企业，应查明原因，并在日常监管中加大检查力度和频率。</p><p><br  /></p><p style="text-indent: 0em; 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="text-indent: 0em; 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 &nbsp;&nbsp;</span><span style="font-size: 14px; line-height: 1.75em;">&nbsp; &nbsp;&nbsp;</span></p><p style="text-indent: 0em; 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="font-size: 14px; line-height: 1.75em;">邮编：510507</span></p><p style="text-indent: 0em; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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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="text-indent: 0em; 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="text-indent: 0em; 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; 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word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p style="line-height: 21.3333px;"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p><br  /></p>