Every year FDA releases an annual report for Quality system inspections and enforcement action data for the Medical Device industry. For our blog this week, we are presenting a brief analysis of the data published by the FDA for the fiscal years 2015, 2016 and 2017 prior to the release of the FY 2018 data in December. Here are some of our key observations from the current data..

1. A Brief Analysis of Medical Device Quality
System Enforcement Actions [2015 -2017]
By: Nikita Angane, MS
Every year FDA releases an annual report for Quality system inspections and
enforcement action data for the Medical Device industry. For our blog this week, we are
presenting a brief analysis of the data published by the FDA for the fiscal years 2015, 2016 and
2017 prior to the release of the FY 2018data in December. Here are some of our key
observations from the current data.
In 2015, 2016 and 2017, FDA conducted 2271, 2246 and 2235 inspections respectively.i
The number of inspections has remained fairly consistent; however, the breakdownof the
number of domestic and international sites is noteworthy.
FIG Ai
The number of International sites inspected by the FDA increased from 674 in 2015 to
760 and 727 in 2016 and 2017 respectively, which could be an indication of more and more
foreign manufactured products entering the US market or US companies outsourcing their
manufacturing, thereby requiring the need of FDA inspecting the said international sites. It is
worth noting that there is a gap in the literature, and any applicable publications, surrounding
any explanation behind the number of domestic or foreign sites’ inspections.
The number of 483s issued to medical device companies for quality system violations
showed an increase of only 14% from 2016 to 2017 in comparison to the drastic decline in the
number of warning letters issued.
FY 2015 FY 2016 FY 2017
1597 1486 1508
674 760 727
NO. OF FDA QUALITY SYSTEM SURVEILLANCE
INSPECTIONSDomestic Foreign

2. Page 2 of 4
FIG Bi
There was a 56% decline in the number of warning letters issued between FY 2016 and
2017, and a 41.4% drop between the FY 2015and 2016.
Let’s take a peek at the trends in the QSR subsystem citations in the 483s and warning
letters.
CAPA and Production and Process Controls continue to remain the most frequently cited
observations in all three years.
FIG Ci
970
863
976
2271 2246 2235
128 75 33
0
500
1000
1500
2000
2500
FY 2015 FY 2016 FY 2017
483s, WL and total QS inspections
No. of 483 Total QS inspections WL with QS citation
0
200
400
600
800
1000
1200
1400
P&PC CAPA Design control Management control Doc control
Form 483 observations by QS subsystem
FY 2015 FY 2016 FY 2017

3. Page 3 of 4
FIG Di
Fig E. below shows the share of CAPA and P&PC citations in warning letters issued since
2015. CAPA and Production and Process Controls appeared in more than 50% of the total
warning letters each year.
The other citations in the warning letters include violations in design control,
management control, and document control.
FIG Ei
Fresh data (for FY 2018) is soon to be released, but until then we will have to wait to see
what new trends would highlight. We will monitor the trends and keep you updated on what we
find out from the new 2018data.
0
50
100
150
200
250
300
P&PC CAPA Design control Management control Doc control
Warning letters citations by QS subystems
FY 2015 FY 2016 FY 2017

4. Page 4 of 4
If your company needs help with Quality System remediation, 483 or warning letter
responses, please call (248) 987-4497 or send an email to info@emmainternational.com.
1. i
Data Source: FDA (Dec 2017) FY2017 Annual FDA Medical Device Quality System Data
retrieved on 11-16-2018 from
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandToba
cco/CDRH/CDRHTransparency/UCM597261.pdf