Half-year Report 2012: FDA Medical Devices Warning Letter Statistics

We regularly analyse 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 2012 (from 1st October 2011 to 15 March 2012). The number of Warning Letters (81) issued by the Center for Devices and Radiological Health (CDRH) in the first half of fiscal year 2012 is comparable to that issued in the first half of fiscal year 2011 (87 Warning Letters). Among the 81 Warning Letters issued, "only" 68 refer to cGMP requirements for medical devices (Quality System Regulations (QSR)) in 21 CFR 820.

The Top 5 ranking doesn't offer anything particularly new. As often in recent years, the first place goes to CAPA deficiencies. Complaint Files deficiencies comes in 2nd, place 3 goes to deficiencies in Design Controls. Compared to 2011, they have swapped places. As in 2011, deficiencies in Purchasing Controls ranks 4th and deficiencies regarding chapter 21 CFR 820.80 (Receiving, in-process, and finished device acceptance) is on the 5th place. Compared to 2011, 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" (the many deficiencies relative to Complaint Files are significant for this subpart) rank 1st. Place 2 goes to the subpart "CAPA". On the 3rd place is the subpart "Production and Process Controls" (which also includes process validation). The subparts "Quality Systems Requirements" and "Design Controls" share rank 4, and the subpart "Acceptance Activities" comes in 5th.

Complete statistics of the Warning Letters issued in the fiscal years 2002 to 2011 can be found in the GMP News from 9 November 2011.

Conclusion: Compared to 2011, the Top 5 deficiencies regarding cGMP requirements for medical devices (Quality System Regulations (QSR)) im 21 CFR 820) in the first half of fiscal year 2012 have remained almost unchanged (except for Complaint Files and Design Controls which swapped places). After the end of fiscal year 2012 (by the end of September 2012), Concept Heidelberg will release the final statistics.

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

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