What is new with regard to Warning Letters for Medical Device Manufacturers?

The number of Warning Letters the Center for Devices and Radiological Health (CDRH) and the corresponding "District Offices" issued in the first half of the fiscal year 2015 is 39 and thus relatively low. Assuming that the Warning Letters throughout the year are evenly distributed, this would mean a total of 78 in the entire 2015 fiscal year. Compared to the fiscal year 2014 it would be a reduction (98 Warning Letters as a whole). From the Warning Letters issued in the first half of the fiscal year 2015 30 refer to the cGMP rules for medical products (Quality System Regulations (QSR)) in the 21 CFR 820. Following you will find an evaluation of these Warning Letters.

The result of the top 5 deficiency list shows "old acquaintances". And the top 3 are virtually unchanged. As most of the time in recent years deficiencies with regard to CAPA remain No. 1. Deficiencies regarding "Complaint Files" follow as No. 2, and on 3rd place deficiencies with regadr to  "Design Controls" can be found. New in the top 5 are deficiencies relative to "Production and Process Controls" (21 CFR 820.70) on the 4th place. The last time "Findings" with regard to this paragraph were in the top 5 was in 2007. "Purchasing Controls" (21 CFR 820.50) shortcomings are on the 5th place. This is similar to recent years (2014: 4th place, 2013: 5th place).

Also interesting is how the numbers of the criticised deficiencies are assigned to the various "subparts" of 21 CFR 820. Subpart "Records" takes 1st place (due to the many deficiencies relative to "Complaint Files", which are covered in this subpart). Subpart "Production and Process Controls" takes 2nd place (also including the subject process validation). On 3rd place is the subpart CAPA, followed by the subpart "Design Controls" on 4th place. Finally, subpart "Quality System Requirements" takes place 5.

For further Warning Letters statistics for the fiscal years 2002-2013 please see the GMP-news from November 2013 (Medical Devices Warning Letter Statistics 2013 - Rank 1 for CAPA Deficiencies once more).

Conclusion: Actually nothing new? Yes, but the total number of Warning Letters seems to level off slightly lower than in the years 2010-2013 (over 100 Warning Letters in the respective fiscal year). The top 5 deficiencies are virtually unchanged. "Rising stars" are the deficiencies with regard to "Production and Process Controls" on the 4th place.

PS: All delegates of the ECA Education Course "GMP for Medical Devices" from 30th September-1st October 2015 in Heidelberg, Germany, will receive the FDA Medical Device Warning Letter Navigator on CD-ROM with the new Warning Letter results from 2002 - 2014 (including above mentioned statistics).

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