Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5

On behalf of the Eurpean 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 the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). 

The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher than that issued in the first half of fiscal year 2012 (81) and 2011 (87 Warning Letters). Among the 107 Warning Letters issued, "only" 79 refer to cGMP requirements for medical devices (Quality System Regulations (QSR)) in 21 CFR 820). Also this number is much higher than that of 2012 (68). Please find in the following an analysis of these Warning Letters.

The Top 5 ranking presents a few new things, whereby the top 3 has remained almost unchanged. As often in recent years, the first place goes to CAPA deficiencies closely followed by "Complaint Files" and deficiencies on "Design Controls" on place 2 (on place 3 at the same period in 2012). Place 3 is also shared by two requirements from the CFR 820: deficiencies on "Purchasing Controls" and on "Device History Records" (21 CFR 820.184). Deficiencies on "Device History Records" are newcomers in the top 5 ranking of the first half-year 2013. They were on place 7 in the same period of 2012 (see our GMP News from 6 June 2012). Place 4 goes to deficiencies on "Production and Process Controls" (2nd half-year of 2012: place 6). Deviations from chapter 21 CFR 820.80 (Receiving, in-process, and finished device acceptance) rank the second place. Compared to 2012, this has remained unchanged.

The classification of the number of criticised deficiencies regarding the "Subparts" of 21 CFR 820 is also interesting. The subpart "Records" ranks 1st (the many deficiencies relative to "Complaint Files" are significant for this subpart). Place 2 goes to the subpart "Production and Process Controls" (which also includes process validation) - closely followed by the subpart "Quality Systems Requirements" on the 4th place. Subpart "CAPA" ranks 5th - and subpart "Design Controls" occupies position 6.

You can find further statistics of the Warning Letters issued between fiscal year 2002 and 2012 in our GMP News from 14 November 2012.

Conclusion: The top 3 hit list of deviations hasn't really changed compared to the first half-year of 2012 (only deficiencies on "Design Controls" now share place 2 with deficiencies on "Complaint Files" ). New in the Top 5 hit list are deviations from "Device History Records" (21 CFR 820.184) on place 3 and deficiencies on "Production and Process Controls" on place 4. Place 5 (deviations from Chapter 21 CFR 820.80) has remained the same compared to 2012.

After the end of fiscal year 2013 (by the end of September 2013), Concept Heidelberg will release the final statistics.

PS: During the ECA course "GMP for Medical Devices", on 17/18 September 2013 in Berlin, Germany, you will receive as free add-on a detailed analysis of all Warning Letters issued between 2002 and the first half year 2013 in the form of the current "Medical Device Warning Letter CD".

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