FDA15年检查数据信息图

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15 Years of FDA Inspection Data: Infographic


2015 年 9 月 4 日 选自：http://t.co/LbmgvzgCRK


Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection? Over the past year, we’ve worked to get at this data and published this first infographic focused on FDA inspections.


As you might imagine, the FDA has had a busy 15 years. Over that time period, they conducted 600,000+ inspections spanning 150,000+ facilities, issuing 130,000+ FDA 483s, and utilizing 4,500+ inspectors.


THE MIX OF FDA INSPECTIONS HAS CHANGED DRASTICALLY
Looking at the inspections year by year, FDA has gradually ramped up the number of inspections each year, starting at around 30,000 in 2000, and peaking at 46,000 in 2011. 483s issued roughly mirrored that trend as well.


Inspection duration has roughly stayed at about 3-4 days, though 3.8 days in 2014 was an all-time high. This could potentially be due to the increased focus on international inspections, which have tripled over the last six years. This is possibly the key take-away from this infographic.


International inspections remained constant – at around 800-900 from 2000 to 2008. An obvious, intentional shift in strategy began in 2009, which corresponds to a changing of the guard (Commissioner Hamburg took over for Commissioner Eschenback). Nonetheless, this is not a surprise, as the FDA has publicly announced this increased intensity overseas to match the volume of pharmaceuticals manufactured overseas.


We have seen this very clearly in our business as well. More and more of our customers are coming from overseas, as they prepare for their FDA inspections, sometimes for the first time. Just last week, customers from Turkey and Taiwan contacted us on the same day.


FDA INVESTIGATORS: LOTS OF VETERANS & ROOKIES
Looking specifically at the inspector data is also quite interesting. Out of the 4,500 inspectors utilized over the last 15 years, only 1,500 are active. That means 1,500 inspectors have inspected at least one facility in the last 12 months. As we looked at this data, it seemed that many of the inspections from 2000 to 2005 utilized inspectors that only inspected one facility. Perhaps the FDA transitioned strategies to dedicated inspectors as time passed.


These active inspectors have inspected an average of 122 facilities. Despite a massive hiring surge of new inspectors, there is still a large contingent of very experienced inspectors in the field – almost 750 inspectors have inspected at least 101 facilities. There are also a lot of “rookies”, with 177 inspectors with 4 or less inspections under their belts. Of course, these rookies are getting mentoring and in-the-field training from their more experienced counterparts.


All in all, we expect to see the FDA continue to ramp up international inspections, using their most experienced inspectors to lead those inspections. What do you see in these numbers?


All of this data is interesting for an infographic, but the true value lies in the specifics. We have all this granular data about inspections linked with inspectors, sites, 483s, and warning letters.  Now, you can drill down into a specific inspector or site or area - and see related 483s and warning letters. If you are interested in  slicing and dicing this data , please check out Enforcement Analytics.

孩子他爸

给翻译下发上来啊~~整不明白

心里有数

直到最近,它一直难以获得FDA检查数据。当然,FDA发布每年聚合数据,但是细粒度的数据在每一个检验呢?在过去的一年里,我们努力得到这个数据,发表第一个信息集中在FDA检查。


你可能会想象,FDA有繁忙的15年。在这段时间内,他们进行了跨越150000 + 600000 +检查设施,发行130000 + 483年代FDA,利用4500 +检查员。


FDA的检查已大大改变了
看着逐年检查,FDA已经逐渐加大检查的数量每年在30000年开始于30000年,46000年在46000年达到顶峰。483年代发行的大致反映了这一趋势。


检验时间呆在大约3 - 4天左右,尽管2014年3.8天是空前高涨。这可能是由于增加的关注国际检查,已过去六年增长了两倍。这可能是外卖从这张资讯图像的关键。


国际检查保持不变——在800 - 900从2000年到2008年。一个显而易见的,故意转移策略始于2009年,对应于一个改变的(专员Eschenback专员汉堡接管)。尽管如此,这并不意外,因为FDA已经公开宣布这个强度增加海外匹配海外制药生产的数量。


我们已经看到这个非常清楚我们的业务。越来越多的客户来自海外,他们准备FDA检查,有时第一次。就在上周,客户来自土耳其和台湾联系我们在同一天。


FDA调查人员:很多退伍军人和新秀
具体看检查员数据也很有趣。的4500检查员使用在过去的15年,只有1500是活跃的。这意味着1500年核查人员检查至少一个设备在过去的12个月。当我们看这些数据,似乎从2000年到2005年,许多检查利用检查员,只检查一个设施。也许FDA策略转变为专用的检查员随着时间的推移。


这些活跃的检查员检查平均122设施。尽管大规模招聘的新人员,还有一大群领域很有经验人员,近750名核查人员检查至少101设施。也有很多“新秀”,与177检查员检查4或更少在他们的腰带。当然,这些新秀得到指导,从更有经验的同行领域的培训。


总而言之,我们希望看到美国食品药品管理局继续加大国际检查,使用他们的领导那些最有经验的检查员检查。在这些数字你看到什么?


所有这些数据很有趣的信息,但真正的价值在于细节。我们都这个细粒度的数据检查与核查人员,网站,483年代,警告信件。现在,您可以深入到一个特定的检查员或网站或区域,看到相关的483年代和警告信。如果你有兴趣切割这些数据,请查看执行分析

beiwei5du

孩子他爸 发表于 2015-9-12 08:17
给翻译下发上来啊~~整不明白

主要就是汇总一下最近15年FDA的检验员结构，被检查的药厂数量，检查数量，检查发出的483，国际检查数量等等情况，看哪个信息图比较直观。

beiwei5du

心里有数 发表于 2015-9-12 09:08
直到最近,它一直难以获得FDA检查数据。当然,FDA发布每年聚合数据,但是细粒度的数据在每一个检验呢?在过去的 ...

hihi!谢谢你的翻译，但是有一些次翻译有偏离哦！

心里有数

beiwei5du 发表于 2015-9-12 09:12
hihi!谢谢你的翻译，但是有一些次翻译有偏离哦！

不用谢我，谢Google，不够智能，差错在所难免，举手之劳

xqliu

学习一下啦，谢谢提供分享。