On behalf of the European Compliance Academy, the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for fiscal year 2013 (from 1st October 2012 to 31 September 2013).
We've already drawn up an interim report of Medical Device Warning Letters for the first half of fiscal year 2013. Since then there have been a few changes. In the following, you will find targeted comparisons with the previous fiscal years.
The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) in fiscal year 2013 (199 Warning Letters) has set a new record (181 were issued in 2012). Among the 199 Warning Letters issued in fiscal year 2013, "only" 159 refer to cGMP requirements for medical devices (Quality System Regulations (QSR) in 21 CFR 820).
Regular acquaintances rank the top 5. The results are very similar to those of fiscal year 2012 (see our GMP News from 14 November 2012). The first place goes to CAPA deficiencies - as in the past between 2008 and 2012. "Complaint Files" deficiencies get the second place. In 2012, they shared this place with CAPA deficiencies. Place 3 goes to deviations on "Design Controls" (from 2010 to 2012 they had place 2). Deviations from Chapter 21 CFR 820.80 (Receiving, in-process, and finished device acceptance) get rank 4, whereas they got place 3 in 2012. Besides, "Purchasing Controls" finished fifth (2011/2012: rank 4) .
The classification of the number of criticised deficiencies regarding the "Subparts" of 21 CFR 820 is also interesting. The subpart M "Records" ranks 1st which seems to be due to the fact that many deficiencies relative to Complaint Files are significant for this subpart. Place 2 goes to the subpart "CAPA". Place 3 goes to the subpart "Production and Process Controls" (which also includes process validation). The subpart "Quality Systems Requirements" gets place 4 and "Design Controls" place 5.
The following table compares the evolution in the previous years:
|Year||Number WLs||Top 1||Top 2||Top 3||Top 4||Top 5|
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 control
21 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: Nothing has really changed in the FDA Medical Devices Warning Letter Statistics of fiscal year 2013. It is just surprising to see that the global number of Warning Letters (mainly issued in the first half of the year) increased compared to last year. Regular acquaintances rank the top 5 and were also listed in the top 5 Warning Letter Statistics over the last years.
PS: You can purchase the Medical Device Warning Letter CD to get a more detailed analysis for € 99, - on the ECA website.