FDA publishes Analysis of 2010 Warning Letter Statistics regarding Medical Devices

The FDA has recently published a document on Quality System Data. This document actually presents the analysis of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) to medical device firms in 2010.

In this case, the analysis relies on the calendar year (January – December 2010) and not on the fiscal year (October of the previous calendar year - September of the current year) as usual. The FDA categorises the 21 CFR 820 (Quality System Regulations) in 5 subparts (in brackets you will find the respective paragraphs from 21 CFR 820 and their subpart):

  • Process and Process Control (820.50, .60, .70, .72, .75, .80, .86, .120, .130, .140, .150, .160, .170, .200, .250)
  • CAPA (820.90, .100, .198)
  • Management (820.5, .20, .22, .25)
  • Design (820.30)
  • Documentation (820.40, .180, .181, .184, .186)

The FDA issued 89 Warning Letters between January 2010 and December 2010. 81 out of the 89 Warning Letters also concerned the subpart CAPA (91%, in total 186 cites), 69 Warning Letters concerned Process and Process Control (78%, in total 168 cites), 43 Warning Letters concerned Management (48%, in total 80 cites), 49 Warning Letters concerned Design (55%, in total 72 cites) and 33 Warning Letters concerned Documentation (37%, in total 71 cites).

Referring to single paragraphs, here is the Top Five list of Deficiencies for Medical Devices


  • 21 CFR 820.198 (Complaints)
  • 21 CFR 820 100 (CAPA)
  • 21 CFR 820.30 i+g (Design Controls)
  • 21 CFR 820.75 (Process Validation)
  • 21 CFR 820. 22 (Quality Audit)
  • Looking at the Warning Letter History (back to 2003), we can notice that the CAPA subpart has always ranked place 1.

    Details about Process Validation deviations are dealt with separately. 40% of all 2010 Warning Letters concerned cites regarding deficiencies from 21 CFR 820.75 (a – c) and 21 CFR 820.70 (b, i).

    Concept Heidelberg regularly analyses the FDA Medical Devices Warning Letters (see GMP-News from 3 March 2011). However, this evaluation is not based on the subparts and for the fiscal year 2010 (October 2009 – September 2010). This explains the slight differences that can be found in the results. Still, regarding the Top 5 deviations, 4 are the same (Complaints, CAPA, Design Controls and Validation).

    The FDA analysis can be found here.

    Conclusion: Again, the FDA analysis of the deviation citations for the calendar year 2010 presents Complaints and CAPA on places 1 and 2. Place 3 is occupied by deficiencies to Design Controls, place 4 by Process Validation deficiencies and place 5 by Quality Audits deficiencies.

    Sven Pommeranz
    CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

    PS. As a response to the increasing importance of the Process Validation topic - even for the manufacture of medical devices - ECA is organising the education course Medical Devices Validation Manager in Heidelberg, Germany, on 18/19 January 2012. A Certification can be granted after attending the course and successfully passing an online exam.

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