Medical Devices Warning Letters Report 2008 - CAPA 1st

CONCEPT HEIDELBERG regularly evaluates the FDA warning letters. In the following, the development of the top 5 "hit list" of warning letters regarding medical devices from the years 2002 to 2008 is described. The years mentioned refer to FDA's fiscal years (October of the previous year until September of the year in question).

After very high numbers of warning letters issued in the years 2004 (104) and 2005 (106) and somewhat lower numbers in 2007 (78) and in 2006 (79), the total number of 123 warning letters regarding medical devices sent out in 2008 appears to be higher again. Having a closer look at these warning letters, one sees, however, that "only" 77 of them refer to the Quality System Regulations (QSR) in 21 CFR 820. In this respect, the year 2008 can more or less be compared to 2006 and 2007 (79 and 78 warning letters).

After going down to second rank in 2006, CAPA deficiencies are again in the lead. The second rank is now occupied by deficiencies regarding complaint files, deficiencies in design controls have gone down to 3rd rank. Deviations concerning management responsibility are again among the top five, namely ranking 4th. Not for the first time, deficiencies regarding 21 CFR 820.80 rank 5th. A conspicuous difference to last year is the high number of deviations concerning the Quality System Requirements. Deficiencies regarding management responsibility (21 CFR 820.20) rank 4th, deficiencies in the quality audit (21 CFR 820.22) rank 6th and deficiencies regarding personnel (21 CFR 820.25) 8th.

The following table gives an overview of the top 5 deficiencies:

WLs: Warning Letters
The table only lists the right part of the CFR name.

  • 21 CFR 820.20: Management responsibility
  • 21 CFR 820.22: Quality audit
  • 21 CFR 820.30: Design 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 820.100: Corrective and preventive action
  • 21 CFR 820.198: Complaint files

The ECA offers an Education Course "Deviation Management and CAPA" in Vienna, Austria, on 19-20 May 2009 . During this course, you will get to know all relevant aspects for implementing and/or improving your Deviation Management and CAPA System fulfilling regulatory GMP requirements.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

PS. Are you interested in validation requirements. ECA´s Validation Manager Course is scheduled for 30 September - 2 October 2009 in Barcelona, Spain.

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