关于江西美琳康大药业股份有限公司检查情况的通告（2023年第32号）20230719
发布时间：2023-07-19
近期，国家药品监督管理局组织检查组对江西美琳康大药业股份有限公司进行了飞行检查。检查发现该企业质量管理体系主要存在以下缺陷：
一、厂房与设施方面
企业环氧乙烷灭菌室和解析室两室互通，无物理隔离，存在交叉污染风险，不符合《医疗器械生产质量管理规范》和《医疗器械生产质量管理规范附录无菌医疗器械》（以下简称《规范》及无菌附录）中厂房与设施应当根据所生产产品的特性、工艺流程及相应的洁净级别要求进行合理设计、布局和使用的要求。
二、设计开发方面
企业原材料无纺布新增加的供应商与原供应商提供的原材料质检报告所用标准不一致，且未开展相关验证，不符合《规范》及无菌附录中当选用的材料、零件或者产品功能的改变可能影响到医疗器械产品安全性、有效性时，应当评价因改动可能带来的风险，必要时采取措施将风险降低到可接受水平，同时应当符合相关法规的要求。
该企业质量管理体系存在严重缺陷，不符合《规范》及无菌附录相关规定，该企业已对其质量管理体系存在的上述缺陷予以确认。
江西省药品监督管理局应当按照《医疗器械监督管理条例》第七十二条规定，对企业依法采取暂停生产的控制措施，对涉及违反《医疗器械监督管理条例》及相关规定的，应当依法处理；并责令该企业评估产品安全风险，对有可能导致安全隐患的，按照《医疗器械召回管理办法》的规定召回相关产品。
该企业完成全部项目整改并经江西省药品监督管理局复查合格后方可恢复生产。
特此通告。
国家药监局
2023年7月14日
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