FDA published their 2015 Annual Medical Device Quality System Data including inspections, form 483 observations and warning letter deficiencies. The 35-slide deck includes many graphics for those of you who prepare reports for your management. Note that this information is collated by calendar year and not fiscal year as the previously published FDA enforcement reports are collected and reported. Would that all of FDA would get onto the same page regarding reporting periods.
High level conclusions from the deck along with the referenced slide are:
- The number of QS Surveillance inspections decreased continually from 2011 through 2015 with the exception of 2014 where the number increased by 14 over the previous year. (slide 6)
- The number of domestic inspections are lower in 2015 than they have been since 2008; Foreign inspections continue to increase as they have done since 2008. (slide 6)
- Foreign inspections as a percentage of the total inspection conducted varied between 13% and 17% from 2008 through 2012. They were 21% of the total in 2013, 27% in 2014 and 29% in 2015 (calculated from data in slide 6). It would be interesting to know what percentage of devices were imported each year for comparison purposes.
- China, Germany, followed by Japan were the top three foreign inspection sites for the past two years. (slide 7)
- The top three countries for OAI inspection outcomes in 2015 are China, the UK and Germany. Japan is 4th. (slide 10)
- OAI classification stayed at 7-8% between 2008 and 2013, rose to 9% in 2014 and 11% in 2015. NAI classification in 2015 dropped dramatically from 54% in 2014 to 45%. Between 2008 and 2013 the values ranged between 50% and 54%. (slide 8)
- OAI classification in 2015 was 10% for domestic inspections and 15% for foreign inspections. (slide 9)
- However, the percentage of warning letters issued for total foreign inspections ranged from 17% in 2012, 16% in 2013, 8% in 2014 and 10% in 2015. The percentage of warning letters issued for domestic inspection in 2015 is 4% (calculations from data in slides 6 and 26). OAI classification thus does not seem to mean that a warning letter was issued, see data in slide 9.
- CAPA and Production and Process Controls were the top two subsystems for inspection observations. These have been the top two categories, by far, since 2004 (slide 17)
- CAPA and Production and Process Controls were the top two citations in warning letters in both 2014 and 2015. (slide 28)
- An area where there seems to have been dramatic improvement, relative to the number of inspection observations, is Management Responsibility. The number of inspection observations in 2004 was slightly over 800 and in 2015 is slightly under 400. (slide 17)
- The number of warning letters with Quality System deficiencies are the same in 2015 as they were in 2014 but lower than they have been since 2011. (slide 25)
- For the four years where warning letter data are provided for both domestic and foreign inspections, the percent of the total warning letters issued to foreign sites varies from: 40% in 2012; 51% in 2013; 37% in 2014 and 49% in 2015. (calculated from data in slide 26)
A recent blog entry addressed inspection observations and warning letters issued by CDER.