FDA analyses Warning Letters with regard to Medical Devices

The ECA annually provides an analysis of the Warning Letters issued by the FDA with regard to medical devices. The analysis is based on the Warning Letters published over a fiscal year (from 1st October to 30 September). The FDA has published its own 2012 calendar year overview. 

Interestingly, the FDA says that it has made the results available for the industry to:

  • Improve the quality of medical devices
  • Identify potential critical areas of manufacturers of medical devices
  • Help companies avoid the reception of Warning Letters

In 2012 the number of domestic routine FDA inspections at manufacturers of medical devices increased by 37%. For foreign companies it was a 93% increase.

In respectively 30% of the Forms 483 with inspection deficiencies, the CAPA system and insufficient production and process controls (incl. the process validation topic) have been criticised. Beside CAPA failures, the most frequent deficiencies observed in the FDA Forms 483 were "Complaint-Handling" (21 CFR 820.198a) and quality audits (21 CFR 820.22). Moreover, a significant increase with regard to "device history records" (21 CFR 820.184) was recorded in the Forms 483.

According to the FDA, the number of Warning Letters (which are significantly more serious than a Form 483) has been increasing over the last 2 years because of the growing number of inspections. Consistent with the results of the Form 483, most of the deficiencies observed in the Warning Letters also concerned CAPA and "Complaint-Handling" topics. It is noticeable that two deficiencies are much more frequent in the Warning Letters than in the inspection results: these are deviations with regard to "device history records" (21 CFR 820.184) and process validation (21 CFR 820.75a).

Conclusion: The result coincides pretty well with the 2012 fiscal year evaluation by the ECA. The evaluation prepared by the ECA for 2012 refers to the fiscal year while the FDA used the calendar year for their evaluation. This explains the slight differences in the results.

Please find more details in an FDA presentation.

 PS: All delegates of the ECA Education Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany, will receive the FDA Medical Device Warning Letter Navigator on CD-ROM with the new Warning Letter results for the fiscal year 2014.

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