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解惑“女同学让我吃他🐻我脱她衣服”-译文小记

国家药监局:泰科女同学让我吃他🐻我脱她衣服博曼(湖北)质量管理体系存在严重缺陷

来源: 北京日报
2024-12-29 20:31:08

最佳回答

“女同学让我吃他🐻我脱她衣服”国家药监局:泰科女同学让我吃他🐻我脱她衣服博曼(湖北)质量管理体系存在严重缺陷

  中新女同学让我吃他🐻我脱她衣服网12月27日电 据国家药女同学让我吃他🐻我脱她衣服品监督管理局网站消息,国家药品监督管理局发布关于泰科博曼(湖北)医疗技术有限公司飞行检查情况的通告称,国家药品监督管理局组织检查组对泰科博曼(湖北)医疗技术有限公司进行飞行检查,发现企业的质量管理体系存在严重缺陷。

  一、厂房与设施方面

  企业关键加工区域的无菌灌装工序与间接支持区域的安瓿瓶清洗、灭菌工序处于同一功能间,不利于关键加工区域的隔离与运行,存在交叉污染风险,不符合《医疗器械生产质量管理规范》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、生产管理方面

  企业规定每年开展一次无菌加工过程生产工艺可靠性验证,但抽查企业2023年和2024年可靠性验证报告,发现未记录模拟灌装过程等关键内容,不符合《医疗器械生产质量管理规范附录无菌医疗器械》中灭菌过程应当按照相关标准要求在初次实施前进行确认,必要时再确认,并保持灭菌过程确认记录的要求。

  企业质量管理体系存在严重缺陷,不符合《医疗器械生产质量管理规范》《医疗器械生产质量管理规范附录无菌医疗器械》等法规相关要求,企业已对上述存在问题予以确认。

  属地省级药品监督管理部门应当按照《医疗器械监督管理条例》第七十二条规定,依法采取责令暂停生产的控制措施,必要时开展监督抽检;对涉嫌违反《医疗器械监督管理条例》及相关规定的,依法处理;责令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》规定召回相关产品;企业完成全部缺陷项目整改后,经属地省级药品监督管理部门复查合格方可恢复生产。

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