FDA的检查结果483统计分析Statistical Analysis of FDA's Inspection Findings

清歌一曲月如霜

FDA的检查结果统计分析Statistical Analysis of FDA's Inspection Findings

FDA检查员发现的不足之处是记录在所谓的483表.这些都不是可在网上，并且必须通过邮局单独请求。然而，根据其频率，FDA对列出的结果的评估是相当不明的。这是一个非常简单的方法来找出常见的不足之处。在“药品”领域，例如，缺乏或不符合书面要求是排在第一位。第二位置进入到在偏差的调查故障。
观察总结计数超过5.000483表格 - 包括除毒也进一步领域，如食品已经分别进行了分析。
另外一个有趣的总结是关于483表的常见问题网页。
下图显示了在2013财年确定的483的分析。
The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. This is a very easy way to find out frequently observed deficiencies. In the fields "Drugs" for example, the lack of or the non-compliance with written instructions is ranked first. The second position goes to failures in the investigation of deviations.

The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.

Another interesting summary is the webpage with FAQs relating to the 483 Form.

The following graph shows an analysis of the 483 identified during fiscal year 2013.

一沙一叶

这些翻译给你修改了一下。  

怀谷

谢谢！

Master

谢谢分享，学习了

林听

学习了，谢谢分享

陈玉海

英文的啊，学习了

愚公想改行

楼主翻译出来就更好了，许多国外的资料就是因为译者错误让我们误读误解。

bigdogpolice

The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warning Letters, those aren't available online and have to be requested individually by post. Yet, FDA's evaluation of findings listed according to their frequency is pretty unknown. This is a very easy way to find out frequently observed deficiencies. In the fields "Drugs" for example, the lack of or the non-compliance with written instructions is ranked first. The second position goes to failures in the investigation of deviations.
FDA检查员检查到的缺陷是记录在483表格中。不像警告信，483是无法网上查看并且只能针对单独的请求寄出。然而，FDA对按频率所列检查结果的评估仍然不得而知。有条很简单的方法找出常见缺陷。例如在药品中，缺乏或不符合书面规程排列第一。排在第二位的是偏差调查的不足。

The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.
缺陷汇总统计了超过5000份483，除药品外还包括了食品等，这些将单独分析


Another interesting summary is the webpage with FAQs relating to the 483 Form.
另外一个令人关注的统计是FDA网站上和483有关的常见问题及回答（FAQ）

The following graph shows an analysis of the 483 identified during fiscal year 2013.
下图为2013年483的分析

lumang

bigdogpolice 发表于 2014-11-10 15:12
The deficiencies observed by FDA inspectors are written down in the so-called Form 483. Unlike Warni ...

不错！

cctvphcd123

学习......

jingw0910

Thanks a lot~

jingw0910

Thanks a lot~

jeanee

多谢分享               

文竹长的好

厉害了我的神

helloevan

学习了，感谢楼主分享

小金库

谢谢分享！！！