新闻
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China

大唐鼎视等2企业医疗器械被停产整改

2017-08-10 08:34:46   

中国经济网北京8月9日讯 中国经济网记者从北京市食品药品监督管理局获悉,大唐鼎视眼睛护理产品有限公司和北京市亚可康达医疗科技有限公司生产质量管理规范不符合规定及生产质量管理体系存在严重缺陷被停产整改。

北京市食品药品监督管理局对大唐鼎视眼睛护理产品有限公司飞行检查中发现该企业质量管理体系运行中,厂房与设施、文件管理、设计开发及生产管理等方面存在不符合规定的情况。在亚可康达医疗科技有限公司检查时发现,机构与人员、厂房与设施、文件管理、设计开发、采购、生产管理、销售和售后服务、分析和改进等方面存在不符合规定的情况。

经查发现,北京市大唐鼎视眼睛护理产品有限公司生产工艺流程图未包含保存液配制、蒸料等工序,且企业的蒸料工序要求记录物料平衡,但企业未明确相应的计算方法;企业保存液实际配制操作方法与相应的作业指导书中规定的方法不一致。

北京市亚可康达医疗科技有限公司生产现场物品摆放混乱,缺少必要的区域标识、状态标识;企业部分型号产品的设计开发文档未见设计输出文档,针对产品变化未启动设计变更控制文件并形成记录;企业原材料实际分为三类管理,而程序文件规定应分为两类管理;企业产品说明书和标签中未标注产品的有效期。

上述两家企业已对此次飞行检查发现的质量管理体系运行中存在的缺陷予以确认,相关企业上述行为不符合医疗器械生产质量管理规范有关规定,生产质量管理体系存在严重缺陷,北京市食品药品监督管理局针对上述两家企业存在不符合《医疗器械生产质量管理规范》要求的情况,已责成北京市通州区食品药品监督管理局、北京市大兴区食品药品监督管理局责令辖区相关企业停产整改。

404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China

相关阅读

404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
分享到:
0 0
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China

美图推荐

404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China

为您推荐

加载更多>>
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China
404 Not Found

404 Not Found

Sorry for the inconvenience.
Please report this message and include the following information to us.
Thank you very much!

URL: http://3g.china.com:8080/act/news/11038989/20170810/31065634.html
Server: cms-9-53
Date: 2024/12/27 17:28:08

Powered by China
China