24/25 April 2023
The ECA regularly publishes statistics of Warning Letters issued by the FDA to medical devices manufacturers: Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5. For some time, the FDA has also been publishing statistics regarding deficiencies with regard to the Quality System of medical devices manufacturers. Which deficiencies were found by the FDA in 2015?
The objective of FDA’s publication is to improve the quality of medical devices and possibly even help companies avoid receiving Warning Letters. It is interesting to notice that the FDA considers the calendar year (1 January 2015 - 31 December 2015) and not the FDA fiscal year (1 October 2014 - 30 September 2015). In so far, the data may differ from ECA’s statistics which relate to the fiscal year.
In total, the FDA performed 2,104 inspections at medical devices manufacturers (1,484 in the USA and 680 outside the USA) in 2015. This is a slight decrease compared to 2014 (in total 2,213 inspections), whereby the number of inspections outside the USA increased in 2015 compared to 2014 (594). The number of Warning Letters issued in 2015 remained the same as in 2014 (121 WLs). Among the countries outside the USA inspected by the FDA, Germany occupied the second place: 72 inspections were performed in 2014 vs. 90 in 2015. In 2014 and 2015 too, the first place was occupied by China and the third one by Japan.
In 2015, the ranking list of countries outside the USA who received an OAI (Official Action Indicated) was: China (19), United Kingdom and Germany (respectively 10) and Japan (6).
With regard to the 483 deficiencies (in 2015: 3,525 observations from 924 483s), the FDA classifies the deficiencies in subclasses according to the 21 CFR 820:
In 2015, the classification was:
|Quality Subsystem||Number of observations||Percentages|
Yet, in the subsystem P&PC most deficiencies (16%) concern process validation (212 CFR 820.75). In the subsystem CAPA 21 CFR 820 100 (a and b) - which is the requirement from CAPA themselves - are combined with 41% at the top, followed by Complaint Files (21 CFR 820.198a-e) with 37%.
What about the Warning Letters issued in the calendar year 2015?
In total, 121 Warning Letters were issued – exactly the same number as in 2014, whereby the number of warning letters for companies outside the USA increased in 2015 (59) compared to 2014 (45). Considering the Warning Letters, the order of deficiencies is the same in the subsystems as in the 483 observations.
With regard to the individual deficiencies, the Top Five are as follows:
With regard to the individual deficiencies, there are parallels with ECA's analysis of fiscal year 2015. However, the topic Design doesn't appear in the Top 5 of FDA's listing. This is because the FDA assigns design deficiencies to the respective single paragraphs (21 CFR 820.30 a-j). If one would add up all deficiencies on design topics listed in the Top 10, the total result would be 48. That would mean place N°3 as in ECA's analysis of fiscal year 2015.
Conclusion: In both evaluations of fiscal year 2015 and the calendar year with regard to the deficiencies observed during FDA inspections, the frontrunners are the same: CAPA/Complaint Files. Because of the numerous deficiencies concerning process validation, the subsystem "Production and Process Controls" is often criticised too.
For the detailed analysis of calendar year 2015 please see "2015 Annual FDA Medical Device Quality System Data".