ECA新闻：2016财年FDA警告信统计---CAPA仍处于各首位

2016财年FDA警告信统计---CAPA仍处于各首位...



翻译：julia朱玉姣   来源：蒲公英

The news on the Medical Devices Warning Letter Statistics 2015 - What the FDA criticizes at Medical Device Manufacturers from 2 December 2015 already reported about the FDA statistics from 2015 respectively about the Warning Letters Medical Device Manufacturers received. Following you will find the latest developments - with regard to medical devices - in the top 5 list for the fiscal year (FY) 2016 (1 October 2015 to 30 September 2016, as of 3 October 2016). It specifically covers a comparison with the previous fiscal year 2015.

2015年医疗器械警告信统计新闻已经报告了2015年FDA关于医疗器械生产商所收到警告信的统计数据。以下你会看到关于医疗器械最新情况---2016财年（2015年10月1日至2016年9月31日）居清单前5位的缺陷。其中包括了与2015财年的对比。

The number of Warning Letters the Center for Devices and Radiological Health (CDRH) issued in the fiscal year 2016 - 59 compared to 95 in 2015 - is clearly lower. However, from these 59 Warning Letters "only" 54 refer to cGMP regulations concerning Medical Devices (Quality System Regulations (QSR) in 21 CFR 820).

CDRH在2016财年发布的警告信数量明显减少了---相比于2015年的95，2016财年只有59份。但是，从这59份警告信中，“只有”54份引用了CGMP法规（21CFR820中的质量体系法规（QSR））。

Comparable to the last three years, among the top 5 the same deficiencies are on positions 1-3. CAPA deficiencies take the first place - as they already have since 2008. On 2nd place are deficiencies with regard to "Design Controls", which is comparable to the years 2010-2013. "Complaint Files" slipped to 3rd place. Compared to 2015 they changed places with deficiencies relative to "Design Controls". "Purchasing Controls" ranked on place 4 - like the year before, and in position 5 one can find deficiencies regarding "Process Validation".

与近3年相似，在前5位的缺陷中1-3位的缺陷是一样的。CAPA缺陷居首位---自2008年以来一直如此。居次位的是与“设计控制”有关的缺陷，与2010-2013年相似。“投诉文件”滑落到第3位。与2015年相比，“设计控制”相关的缺陷换了位置。“采购控制”则排在第4位---与去年一样，而第5位则是“工艺验证”相关的缺陷。

Also interesting is the country specific distribution of the Warning Letters in the fiscal year 2016 (data from 2015 are not available). From the total of 54 Warning Letters issued due to GMP deficiencies, 17 were addressed to European companies, 9 to Asian companies (China, Taiwan and Japan). From the 17 Warning Letters to European companies 7 came from UK, 4 from Germany, 2 each from France and from Italy and 1 each from Hungary and Greece.

2016财年警告信还有一个有意思的事情是国家分布（2015年的数据没有）。在总共54份由于GMP缺陷签发的警告信中，有17份是发给欧洲公司的，9份是亚洲公司（中国、台湾和日本）。17份给欧洲公司的警告信中，7份来自项国，4份是德国的，法国和意大利各2份，匈牙利和希腊各1份。

Please see the table for a detailed comparison - as in the previous years.

下表是详细的比较信息---与以前的年份相比。

Year 年份

Number WLs

警告信数量

Top 1

第1位

Top 2

第2位

Top 3

第3位

Top 4

第4位

Top 5

第5位

2002

61

.100

.75

.198

.30

.70

2003

61

.100

.30

.198

.20

.80

2004

104

.100

.20

.22

.30

.80

2005

106

.100

.198

.80

.20

.22

2006

79

.100

.30

.198

.80

.75

2007

78

.30

.100

.198

.70/.80

.75

2008

91

.100

.198

.30

.20

.80

2009

84

.100

.198

.30

.20

.22

2010

182

.100/.198

.30

.75

.80

.20

2011

156

.100

.30

.198

.50

.75/.80

2012

181

.100/.198

.30

.80

.50

.90/.184

2013

199

.100

.198

.30

.80

.50

2014

98

.100

.198

.30

.50

.80

2015

95

.100

.198

.30

.50

.75

2016

59

.100

.30

.198

.50

.75

WLs: Warning Letters

The table only lists the rear part of the CFR identification.
21 CFR 820.20: Management responsibility
21 CFR 820.22: Quality audit
21 CFR 820.30: Design controls
21 CFR 820.50: Purchasing controls
21 CFR 820.70: Production and Process control21 CFR 820.75: Process validation
21 CFR 820.80: Receiving, in-process, and finished device acceptance
21 CFR 820.90: Nonconforming product
21 CFR 820.100: Corrective and preventive action
21 CFR 820.184: Device History Record
21 CFR 820.198: Complaint files

Conclusion

结论

There is only little new in the FDA Medical Devices Warning Letter Statistics from the fiscal year 2016. The top 5 are comparable to 2015, only place 3 2015 ("Design Control") now changed places with deficiencies with regard to "Complaint Files".

FDA的2016财年医疗器械警告信统计数据中没有太多新的东西。前5位与2015年相似，只是原来第3位的缺陷（“设计控制”）现在与“投诉文件换了一下位置。

The detailed analysis will be available as Medical Device Warning Letter CD free of charge at the ECA course "GMP for Medical Devices" from 13-14 October in Berlin, Germany.

参加德国柏林10朋13-14日“医疗器械GMP”的ECA会议的人员会免费获得一份医疗器械警告信CD

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