This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.

1. FDA Warning Letters Study
A Look at Warning Letters for Pharma/Biotech, Medical Device,
and Food & Beverage Industries Since 2007
A Warning Letter is official correspondence that notifies the highest-ranking known official of a regulated company
that a serious violation of organizational regulations has been committed. These letters are published on the FDA
website and are available for review by other government agencies, businesses, consumers, and the media.

2. FDA Warning Letters Issued by Year
The average growth rate for warning letters issued between 2007 and 2012 was 15.8% per year. The issuing of
FDA Warning Letters increased 78% from 2007 to 2013, even with a 12.4% decrease from 2012 to 2013.
2007–2012
We wanted to understand: What industries
contributed the most to the increase and why?
2012–June 30, 2014
We believe the decrease was due to fewer FDA inspections
as a result of reduced funding for the FDA1 and an industry-wide
freeze on manufacturers’ FDA fees.
1. http://www.politico.com/story/2013/02/fda-commissioner-margaret-hamburg-2013-budget-cuts-mean-less-safe-food-88241.html
27.5%
Decreased by
comparing the first
6 months of 2013 to the first
6 months of 2014
12.4%
Decreased by
from 2012 to 2013
104%
Total increase of
from 2007 to 2012
Increased by an average of
per year (2007 to 2012)
15.8%

3. Since FDA warning letters are made available to
the public, we did some digging to find which
industries accounted for the highest number of
warning letters. Three industries comprised 95.72%
of all FDA warning letters that were received
between 2007 and 2013.
Pharmaceutical/Biotechnology
Medical Device
Food & Beverage
Industry Comparison
Tobacco
Consumer
Products
Pharmaceutical/
Biotechnology Food & Beverage
Medical Device

4. In 2009, FDA warning letters to Pharma/Biotech companies increased
by 48.59%. The following areas accounted for the increase (actual
numbers):
Pharmaceutical/
Biotechnology
2007
0
50
100
150
200
250
2008 2009 2010 2011 2012 2013
1. http://eng.sfda.gov.cn/WS03/CL0768/65113.html
H1N1
CGMP
Clinical
Trials
In 2011, China’s Ministry of Health
adopted Good Manufacturing
Practice (GMP) requirements1 and
we saw another surge in letters in
the US:
83 letters related to Current
Good Manufacturing Practice
(CGMP)
14 letters related to clinical
investigations (failing trial
research standards)
28 letters for clinical investigations
(failing trial research standards)
33 letters were issued due to violations of
Current Good Manufacturing Practice (CGMP)
35 letters for products related to the H1N1 virus

5. 2007
0
50
100
150
200
250
2008 2009 2010 2011 2012 2013
Medical Device
FACTOR:
Each year, we’ve seen an increase in
consumer access to new medical
device applications and modified
versions of medical devices that
do not require Premarket Approval
(PMA) or Section 510(k) Clearances
from the FDA.2
1. http://www.emergogroup.com/blog/2013/05/fda-data-shows-increase-warning-letters-medical-device-firms-2005
2. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm
A steady increase in letters within the Medical Device industry resulted in the number of
FDA-issued letters nearly
DOUBLING
from 2007 to 2012.1

6. The Food Safety Modernization
Act signed by President Obama
on January 4, 2011 drove a 41%
Food & Beverage
1. http://www.choicesmagazine.org/choices-magazine/submitted-articles/the-fdas-food-safety-modernization-act-and-its-economic-implications
2007
0
50
100
150
200
250
300
350
400
2008 2009 2010 2011 2012 2013
increase in
letters issued to
Food & Beverage
companies.1

7. A Downward Trend in 2014
There have been 267 Warning Letters issued in 2014 so far (as of June 30, 2014), which suggests a downward trend
for the total amount of warning letters for the year. Among the letters received through June 2014, 44% were in the Food & Beverage industry, 26% were in the Pharma/Biotech industry, and 24% were in the Medical Device industry.
69
letters for
Pharma/Biotech
65
letters for
Medical Device
117
letters for
Food & Beverage
16
letters for Consumer
Products & Tobacco

8. RESEARCH BROUGHT TO YOU BY
What’s in Store for 2015 and Beyond
With a proposed significant budget increase for the FDA in 20151, we expect the number of warning letters to
rise significantly for 2015 starting a new upward trend in total warning letters issued in the coming years.
1 http://blogs.fda.gov/fdavoice/index.php/2014/03/whats-new-in-the-fdas-2015-budget/