Department of Health and Human Services 
OFFICE OF 
  
INSPECTOR GENERAL 
 
 
 
   
C R
 HALLENGES  EMAIN IN 
 
FDA I
  S  NSPECTIONS OF 
 
D F F  
OM  ESTIC  OOD  ACILITIES 
 
 
 
 
Daniel R. Levinson 
Inspector General  
 
September 2017 
OEI-02-14-00420   
   
Report in Brief 
September 2 017  
Report No. OEI 02-14-00420   
 
Why OIG Did This  CHALLENGES REMAIN IN FDAS INSPECTIONS OF 
Review   DOMESTIC FOOD FACILITIES  
Each year roughly 48 million 
people in the United States get  What OIG Found 
sick, 128,000 are hospitalized, and 
FDA is on track to meet the domestic food facility 
Key Takeaway 
3,000 die of foodborne diseases.   inspection timeframes for the initial cycles 
To protect against foodborne  mandated by FSMA; however, challenges remain  FDA should do more to 
ensure that the food 
illnesses, the Food and Drug  as FSMA requires FDA to conduct future 
supply is safe by taking 
Administration (FDA) inspects food  inspections in timeframes that are 2 years shorter 
swift and effective action 
facilities to ensure both food  than the timeframes for the initial cycles.  Also, 
to ensure the prompt 
safety and compliance with  inaccuracies in FDAs domestic food facility data 
correction of problems 
regulations.  Congress passed the  result in FDA attempting to inspect numerous 
identified at domestic 
Food Safety Modernization Act  facilities that are either out of business or  food facilities. 
(FSMA), which enabled FDA to  otherwise not in operation at the time of the visit.  
 
 
focus more on preventing food-
Although FDA is on track to meet the FSMA inspection mandates 
safety problems rather than 
during the initial cycles, the overall number of food facilities that FDA 
reacting to them after the fact.  
inspected since the passage of FSMA has decreased from a high of 
FSMA requires FDA to inspect 
about 19,000 facilities in 2011 to just 16,000 facilities in 2015. 
domestic food facilities within 
 
certain timeframes. 
In addition, FDA did not always take action when it uncovered 
How OIG Did This Review  significant inspection violationsthose found during inspections 
classified as Official Action Indicated (OAI).  When it did take action, 
We analyzed data from four 
it commonly relied on facilities to voluntarily correct the violations.  
sources: (1) information about 
Also, it rarely took advantage of the new administrative tools 
facilities that FDA designated high 
provided by FSMA.   
risk and non-high risk pursuant to 
 
FSMA, and whether these facilities  Moreover, FDAs actions were not always timely nor did they always 
were inspected as required;  result in the correction of these violations.  FDA consistently failed to 
(2) FDAs food facility inventory  conduct timely followup inspections to ensure that facilities corrected 
and inspection data from 2010 to  significant inspection violations.  For almost half of the significant 
inspection violations, FDA did not conduct a followup inspection 
2015; (3) information about FDAs 
within 1 year; for 17 percent of the significant inspection violations, 
advisory and enforcement actions, 
FDA did not conduct a followup inspection of the facility at all.   
such as warning letters and 
 
seizures, taken in response to 
What OIG Recommends   
significant inspection violations, as 
We recommend that FDA (1) improve how it handles attempted 
well as whether followup 
inspections to ensure better use of resources, (2) take appropriate 
inspections were conducted for 
action against all facilities with significant inspection violations, (3) 
these violations; and  improve the timeliness of its actions so that facilities do not continue 
(4) structured interviews with FDA  to operate under harmful conditions, and (4) conduct timely followup 
officials.   inspections to ensure that significant inspection violations are 
corrected.  FDA concurred with all four recommendations. 
 
 
 
Full report can be found at http://oig.hhs.gov/oei/reports/oei-02-14-000420.asp   
   
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 
Background ..................................................................................................1 
Methodology ................................................................................................5 
Findings........................................................................................................8 
FDA is on track to meet the inspection timeframes mandated       
by FSMA; however, challenges remain ...........................................8 
Although FDA is on track to meet the FSMA inspection           
mandates, this did not result in a greater number of facilities    
being inspected ...............................................................................10 
FDA did not always take action to ensure that facilities       
corrected significant inspection violations .....................................12 
When FDA did take action, it most commonly relied on facilities   
to voluntarily correct significant inspection violations; these 
actions were not always timely nor did they always result in        
the correction of these violations ...................................................13 
FDA did not consistently conduct timely followup inspections to 
ensure that facilities had corrected significant inspection 
violations ........................................................................................17 
Conclusion and Recommendations ............................................................19 
Agency Comments and Office of Inspector General Response .....21 
Appendices .................................................................................................23 
A:  Detailed Methodology .............................................................23 
B:  Food Facilities Inspected by FDA, 2004 to 2015 ....................27 
C:  FDA Spending for Domestic Food Facility Inspections,     
2004 to 2015 ..................................................................................28 
D:  Time it Took for FDA to Take Regulatory Actions in    
Response to the Significant Inspection Violations,                      
2011 to 2015 ...................................................................................29 
E: Agency Comments ....................................................................30 
Acknowledgments......................................................................................35 
 
 
   
   
OBJECTIVES 
1.  To assess whether FDA is on track to meet the inspection timeframes 
for domestic food facilities mandated by the FDA Food Safety 
Modernization Act.  
2.  To determine whether the inspection mandates increased the overall 
number of domestic food facilities FDA inspected. 
3.  To determine the extent to which FDA takes action in response to 
violations found during domestic food facility inspections. 
BACKGROUND 
Each year roughly 48 million people in the United States get sick, 128,000 
are hospitalized, and 3,000 die of foodborne diseases.1  To help protect 
against foodborne illnesses, FDA inspects food facilities to ensure both 
food safety and compliance with regulations.  In 2016, a flour processor 
initiated a recall after E. coli was found at one of its domestic facilities, 
infecting 63 people in 24 States.2  This outbreakas well as others 
resulting in large recalls of spinach, tomatoes, lettuce, and alfalfa 
sproutsraises questions about FDAs inspections process and its ability 
to protect the Nations food supply. 
To strengthen the food safety system and better protect public health, 
Congress passed the FDA Food Safety Modernization Act (FSMA) and 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).3   
FSMA enabled FDA to focus more on preventing food safety problems 
rather than reacting to them after they occur.4  To that end, FSMA required 
FDA to increase the frequency of its inspections of domestic food 
facilities.5  FSMA also provided FDA with new enforcement authorities 
                        ____________________________________________________________ 
1 Centers for Disease Control and Prevention, CDC Estimates of Foodborne Illness in the 
United States, February 2011.  Accessed at 
https://www.cdc.gov/foodborneburden/estimates-overview.html on October 17, 2016. 
2 FDA, FDA Investigated Multistate Outbreak of Shiga toxin-producing E. coli Infections 
Linked to Flour.  Accessed at http://www.fda.gov/Food/RecallsOutbreaksEmergencies/ 
Outbreaks/ucm504192.htm on October 21, 2016. 
3 FDA Food Safety Modernization Act, P.L. No. 111-353 (enacted January 4, 2011). 
4 FDA, Background on the FDA Food Safety Modernization Act (FSMA).  Accessed at  
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm239907.htm on October 20, 
2016. 
5 Section 201 of FSMA, amending and adding section 421 to the FD&C Act (21 U.S.C.  
350j). 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     1 
 
 
   
   
designed to achieve higher rates of compliance and better respond to 
problems when they occur.6 
This review builds on food safety work conducted by the Office of 
Inspector General (OIG) that identified weaknesses in FDAs food 
inspection program.  In a 2010 review, OIG found that FDA inspected less 
than a quarter of domestic food facilities each year, and that many 
facilities had not been inspected in 5 years or more.7  OIG also found that 
FDA did not always take action against facilities with significant 
inspection violations or take steps to ensure the violations were corrected.  
To date, FDA has not implemented two key recommendations from OIGs 
2010 review: (1) take appropriate action against facilities with significant 
inspection violations and (2) ensure that those facilities correct the 
violations. 
Domestic Food Facility Inspections  
FDA is responsible for ensuring the safety of almost all food products sold 
in the United States, with the exception of meat, poultry, and some egg 
products, which are regulated by the U.S. Department of Agriculture.  As 
part of its efforts to ensure food safety, FDA inspects food facilities that 
manufacture, process, pack, and store food.8  Investigators from FDAs 
19 district offices conduct these inspections according to guidance from 
FDA headquarters.9  In addition, FDA contracts with States to conduct 
inspections on behalf of FDA.   
During the course of FDA inspections, investigators may identify potential 
violations of the FD&C Act as well as other applicable laws and 
regulations.  Investigators document their findings and recommend a 
classification in an inspection report that is reviewed by a district office 
supervisor and in some cases by other FDA officials.10   
                        ____________________________________________________________ 
6 FSMA provided FDA with new and expanded authorities to ensure compliance, 
including the authority to suspend a food facilitys registration (FSMA  102), issue a 
mandatory recall order (FSMA  206), and administratively detain certain foods (FSMA 
 207). 
7 OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), April 2010. 
8 Sections 702 and 704 of the FD&C Act (21 U.S.C.  372 and 374). 
9 FDAs district offices work with FDA headquarters to develop priorities for inspection 
each fiscal year.  Throughout the course of the year, however, FDA may change its 
priorities based on emerging issues such as outbreaks of foodborne illness.  Of FDAs 20 
district offices, 19 conduct food facility inspections.   
10 The inspection classification noted by an investigator is an initial determination, not a 
final decision; in more serious instances, the final decision is made by supervisors or 
other FDA officials.   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     2 
 
 
   
   
When an investigator documents significant, objectionable conditions or 
practices at a facility, the investigator classifies the inspection as official 
action indicated (OAI), which signifies that a regulatory actioneither an 
advisory or enforcement actionis warranted.11  For the purposes of this 
report, we use significant inspection violations to reflect the conditions 
found during a food facility inspection that FDA classified as OAI.    
When an investigator finds objectionable but less significant violations, an 
investigator classifies the inspection as voluntary action indicated (VAI), 
which indicates that the violations are serious enough to record but do not 
meet the threshold for regulatory action.  An investigator can also classify 
an inspection as no action indicated (NAI), which indicates that the 
investigator found no objectionable conditions or practices, or that their 
significance does not justify further action.12  
Advisory and Enforcement Actions 
When FDA finds significant inspection 
violations and classifies the inspection as  Advisory actions 
OAI, an advisory action or an  rely on facilities to 
enforcement action is warranted.13  FDA  voluntarily correct 
violations, while 
uses advisory actions to allow the facility 
enforcement 
to voluntarily correct the violations found 
actions require 
during the inspection.  Advisory actions  compliance. 
include issuing a warning letter or untitled 
                        ____________________________________________________________ 
11 FDA, Office of Regulatory Affairs (ORA): Field Management Directive No. 86:  
Establishment Inspection Report Conclusions and Decisions (rev. 01/28/14).  Accessed at 
http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM382
035.pdf on October 17, 2016.   
12 In addition, inspections may be referred to the State when there is either no Federal 
jurisdiction over the violation in question or when it is determined that State action is the 
most efficient method of obtaining compliance.  Inspections may also be referred to FDA 
headquarters when no clear policy has been established for the violations or significant 
technical issues exist that require a review and decision. 
13 FDA, Regulatory Procedures Manual, ch. 4, 5, 6, 9, and 10.  Accessed at 
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ on 
October 17, 2016.   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     3 
 
 
   
   
letter to the facility or holding a regulatory meeting with representatives of 
the facility.14   
Conversely, FDA uses enforcement actions to require facilities to correct 
the violations, or to destroy adulterated or misbranded products.  
Enforcement actions include seizure, injunction, and even prosecution.15  
In some cases, FDA initiates an enforcement action after a facilitys 
response to an advisory action is inadequate.    
Followup Inspections 
FDA is expected to conduct timely followup inspections of facilities with 
significant inspection violations.  These followup inspections ensure that 
the facility is in compliance and corrects the violations found during the 
initial inspection.16  Followup inspections are not advisory or enforcement 
actions. 
Food Safety Modernization Act (FSMA) 
FSMA aims to ensure that the U.S. food supply is safe by shifting the 
focus from responding to contamination to preventing it.17  Signed into 
law January 4, 2011, FSMA mandated that FDA increase the frequency of 
its inspections of domestic food facilities based on risk.18 
                        ____________________________________________________________ 
14 FDA, Regulatory Procedures Manual, ch. 4.  Accessed at 
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ on 
October 17, 2016.  FDA may issue a warning letter when it finds violations of Federal 
law that may lead to an enforcement action if the violations are not promptly and 
adequately corrected.  FDA may issue an untitled letter when the violations are not 
significant enough to meet the criteria for the issuance of a warning letter.  FDA may 
request a regulatory meeting with representatives of a facility to inform them that its 
products, practices, processes, or other activities are considered to be in violation of the 
law; FDA may hold these meetings when violations do not warrant a warning letter, or in 
combination with the issuance of a warning letter.   
15 FDA, Regulatory Procedures Manual, ch. 5 and 6.  Accessed at 
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ on 
October 17, 2016.    
16 FDA, Office of Regulatory Affairs (ORA): Field Management Directive No. 86:  
Establishment Inspection Report Conclusions and Decisions (rev. 01/28/14), section 6.7.  
Accessed at http://www.fda.gov/downloads/ICECI/Inspections/ Field 
ManagementDirectives/ UCM382035.pdf on October 17, 2016.   
17 FDA, Background on the FDA Food Safety Modernization Act (FSMA).  Accessed  at  
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm239907.htm on October 20, 
2016. 
18 Section 201 of FSMA amended and added section 421 to the FD&C Act (21 U.S.C.  
350j).  FSMA provided FDA with new enforcement tools and eased the criteria for 
administratively detaining potentially unsafe food, provided FDA with authority to 
mandate the recall of certain foods, and allowed FDA to suspend the registration of a 
facility and prohibit that facility from distributing food. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     4 
 
 
   
   
Specifically, FSMA mandated that FDA inspect high-risk facilities at least 
once during the initial 5-year inspection cycle and then at least once every 
3 years for subsequent cycles. FSMA requires that FDA also inspect non-
 
high-risk facilities at least once during the 7-year initial inspection cycle 
and then at least once every 5 years for subsequent cycles.  Prior to 
FSMA, there were generally no timeframes for food facility inspections. 
In 2011, FDA created a list of all domestic food facilities and designated 
each one as high risk or non-high risk for the first inspection cycles.  FDA 
determined whether a facility was high risk based on a variety of factors, 
including whether the facility is associated with outbreaks or recalls or has 
prior violations of food safety standards.19   
Related Work 
OIG is currently conducting a review of FDAs monitoring of domestic 
and imported food recalls.20  In an early alert memorandum released in 
June 2016, OIG raised concerns that FDA does not have adequate policies 
and procedures to ensure that facilities take prompt and effective action in 
initiating voluntary recalls.21  OIG suggested that FDA update its policies 
and procedures to instruct its recall staff to establish set timeframes for (1) 
FDA to request that firms voluntarily recall their products and (2) firms to 
initiate voluntary food recalls.  In response, FDA reported that it expedited 
changes to improve voluntary recall compliance and strengthen its 
enforcement strategies. 
METHODOLOGY 
Scope 
This study focuses on domestic food facility inspections conducted by 
FDA or States under contract with FDA; it does not include inspections of 
                        ____________________________________________________________ 
19 To determine risk, FDA created a model that identifies high-risk facilities based on the 
known safety risks of foods at the industry-wide level and compliance history of the 
facility.  See section 421(a)(1) of the FD&C Act (21 U.S.C.  350(j)(a)(1)). 
20 OIG, Monitoring of Domestic and Imported Food Recalls (W-00-15-50004), 
forthcoming. 
21 OIG, Early Alert: The Food and Drug Administration Does Not Have an Efficient and 
Effective Food Recall Initiation Process (A-01-15-01500).   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     5 
 
 
   
   
foreign facilities22 or inspections conducted under partnership 
agreements.23  It primarily focuses on inspections of domestic food 
facilities conducted in the 5 years after FSMA was enacted.  To provide 
context for the number of facilities that FDA inspected after the enactment 
of FSMA, we included data about the number of food facilities inspected 
from 2004 to 2010. 
Data Sources 
We based this study on data from four sources: (1) information about 
facilities that FDA designated high risk and non-high risk pursuant to 
FSMA, and whether these facilities were inspected as required; (2) FDAs 
food facility inventory and inspection data from 2010 to 2015; 
(3) information about FDA actions such as warning letters and seizures 
taken in response to significant inspection violations, as well as whether 
followup inspections were conducted for these violations; and 
(4) structured interviews with FDA officials.24   
To assess whether FDA is on track to meet inspection timeframes 
mandated by FSMA, we analyzed data from FDAs food facility inventory 
and inspection data.  We started with the lists of high-risk and non-high-
risk facilities that FDA created for each inspection cycle.  We then 
determined the extent to which FDA inspectedor attempted to inspect
these facilities.  Attempted inspections occur when an investigator visits a 
facility but it is either out of business or otherwise not in operation.  FDA 
counts facilities that it attempted to inspect toward meeting the inspection 
mandates.   
Next, we determined the overall number of facilities that FDA actually 
inspected each year from 2004 to 2015.  To do this, we requested from 
FDA data on all facilities known to be under FDAs jurisdiction and the 
number of these facilities that FDA inspected.  This analysis includes 
facilities that were actually inspected and does not include facilities that 
FDA attempted to inspect.   
                        ____________________________________________________________ 
22 The Government Accountability Office (GAO) analyzed inspections of foreign food 
facilities in 2015.  Under FSMA, FDA is required to inspect at least 600 foreign food 
facilities in 2011 and, for each of the next 5 years, inspect at least twice the number of 
facilities inspected during the previous year.  However, GAO found that FDA is not 
currently keeping pace with the FSMA mandate.  See GAO, Additional Actions Needed 
to Help FDA's Foreign Offices Ensure Safety of Imported Food (GAO-15-183), February 
27, 2015.  Accessed at http://gao.gov/products/GAO-15-183 on August 31, 2016. 
23 FDA also has partnership agreements with some States.  These agreements allow States 
to share information with FDA about inspections they conduct, but these inspections are 
not conducted on behalf of FDA.     
24 When determining whether a facility received an OAI, we only considered final 
classifications.  Investigators typically assign an initial classification, which FDA 
supervisors review and finalize. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     6 
 
 
   
   
Last, we reviewed inspections data to determine the extent to which FDA 
identified facilities with OAI classifications from 2011 to 2015.  We 
analyzed the inspections data to determine the extent to which FDA took 
actionsuch as issuing a warning letterand conducted followup 
inspections in response to these significant inspection violations.  See 
Appendix A for a detailed description of the methodology.  
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency.  
   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     7 
 
 
   
   
FINDINGS 
FDA is on track to meet the inspection timeframes 
mandated by FSMA; however, challenges remain 
FSMA requires FDA to inspect domestic food facilities within certain 
timeframes, with high-risk facilities requiring more frequent inspection.  
To implement these requirements, FDA created a list of all domestic food 
facilities and designated each one as high risk or non-high risk.  FDA then 
set out to inspect each facility within the specified timeframes.  If FDA 
does not routinely inspect food facilities, it is unable to ensure that 
facilities are complying with applicable laws and regulations and that the 
food handled by these facilities is safe.  See the text box below for the 
timeframes required for each inspection cycle.   
FDA is on track to meet the inspection timeframes for initial 
cycles  
For the initial cycles, FDA identified 
21,086 high-risk facilities requiring an 
FSMA requires FDA to 
inspection within 5 years from 2011 to 
2015.25  FDA also identified 61,010  inspect all high-risk 
facilities within 5 years 
non-high-risk food facilities requiring an 
for the initial inspection 
inspection within 7 years from 2011 to 
cycle, and every 3 years 
2017.26 
thereafter.  FDA must 
By the end of 2015, FDA inspectedor  inspect all non-high-risk 
facilities within 7 years 
attempted to inspectall but nine of the 
for the initial inspection 
high-risk facilities that required 
cycle, and every 5 years 
inspection under FSMA as part of the 
thereafter. 
first cycle.  FDA counts facilities that it 
 
attempted to inspect toward meeting the 
inspection mandates.  These facilities were either out of business or 
otherwise not in operation when the investigator visited the facility.  
Additionally, with 2 years remaining in the initial 7-year cycle for non-
high-risk facilities, FDA inspectedor attempted to inspect about two-
thirds (40,623) of these facilities.  FDA officials maintain that the agency 
can inspect the remaining facilities by the end of 2017, and FDA appears 
to be on track to do so.   
 
                        ____________________________________________________________ 
25 All years presented in the report are fiscal years. 
26 The number of non-high-risk facilities includes 51,158 facilities that were identified in 
2011 and an additional 9,852 facilities that were added to the list in 2014.  Some of the 
facilities that were added to the 2014 non-high-risk list were initially on the 2011 high-
risk list.  FDA indicated that all of these facilities were to be inspected by the end of the 
first inspection cycle. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     8 
 
 
   
   
Shortened timeframes, inaccurate data, and lack of policy 
pose challenges for future cycles 
Although FDA is on track to meet the inspection timeframes for the initial 
cycles, several factors pose challenges that could affect its ability to meet 
FSMA mandates in the future. 
Shortened timeframes pose challenges for future non-high-risk cycles 
As noted above, the timeframes that FDA is required to meet are shorter 
by 2 years in the second and subsequent cycles than they were for the 
initial cycles.  FDA has demonstrated that it has the ability to meet the 
shorter timeframes for high-risk facilities.  Although FDA had 5 years to 
meet the high-risk mandate for the initial cycle, FDA inspectedor 
attempted to inspectalmost all of those facilities within 3 years.  FDA 
began a second inspection cycle for high-risk facilities in 2014, and it 
appears to be on track to inspector attempt to inspectall high-risk 
facilities within the 3-year inspection cycle. 
However, for non-high-risk facilities, the shorter timeframe poses a 
challenge for future cycles.  FDA either inspectedor attempted to 
inspectan average of 8,125 of these facilities per year from 2011 to 
2015.  If the number of non-high-risk facilities stays approximately the 
same, FDA would have to inspect at least 12,000 each year to inspect all 
non-high-risk facilities within a 5-year inspection cycle.  Unless FDA 
increases its current pace of inspections of non-high-risk facilities, it will 
not be able to meet the mandates for future inspection cycles. 
Inaccurate information consumes inspection resources 
FDAs list of high-risk and non-high-risk facilities to be inspected 
contained inaccurate information about the operational status of some food 
facilities.  As a result, FDA attempted to inspect numerous food facilities 
that were either out of business or otherwise not in operation at the time of 
the visit.  FDA officials noted that the agency expended a considerable 
amount of resources on attempted inspections and that these resources 
might be better used on other activities. 
Specifically, more than one-quarter of the high-risk and non-high-risk 
facilities that FDA counted toward meeting the inspection mandates for 
the initial cycles were out of business or not in operation at the time of the 
unannounced inspection.  Moreover, the proportion of facilities on the list 
that FDA attempted to inspect increased each year.  For example, the 
proportion of non-high-risk facilities FDA attempted to inspect increased 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     9 
 
 
   
   
during the first cycle from 6 percent of the total number of facilities 
inspected in 2011 to 68 percent in 2015.27  
Lack of policy allows some facilities to go without inspection 
Certain food facilities that FDA attempted to inspect in this initial cycle 
still need to be inspected.  For example, a facility that is a seasonal facility 
or temporarily closed on the day an inspection was attempted still requires 
inspection.  FDA does not currently have a policy in place to reschedule
on a timely basisattempted inspections of these facilities to ensure that 
they are eventually inspected.   
 
Although FDA is on track to meet the FSMA 
inspection mandates, this did not result in a greater 
number of facilities being inspected 
FDA did not inspect a greater number of facilities than it had in the years 
prior to implementation of FSMA.  In fact, the number of food facilities 
FDA inspectedexcluding the number of facilities that it attempted to 
inspectdecreased over time, from about 17,000 facilities in 2004 to just 
16,000 facilities in 2015.  Moreover, the number of facilities inspected 
each year since the implementation of FSMA has decreased from a high of 
about 19,000 facilities in 2011 to just 16,000 in 2015.  
As noted earlier, when determining whether FDA meets these mandates, it 
counts attempted inspections as well as completed inspections.  Excluding 
attempted inspectionsas we did in this analysisprovides additional 
insight into FDAs overall coverage of the number of food facilities in the 
food supply that FDA inspects each year. 
Further, as the number of facilities inspected has decreased, the number of 
facilities under FDA jurisdiction has increased.  As a result, the proportion 
of food facilities inspected by FDA in a given year has decreased 
substantially over timefrom 29 percent in 2004 to just 19 percent in 
2015.  Notably, the proportion of facilities inspected has decreased each 
year since the enactment of FSMA, with an overall drop by about a quarter 
from 2011 to 2015.28  See Exhibit 1 and Appendix B for more information 
on inspections of food facilities over time. 
 
 
 
                        ____________________________________________________________ 
27 The proportion of high-risk facilities FDA attempted to inspect also increased during 
the first cycle, from 4 percent of the total number of facilities inspected in 2011 to 39 
percent in 2013. 
28 This analysis does not include facilities that FDA attempted to inspect. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     10 
 
 
   
   
Exhibit 1: Proportion of Food Facilities Inspected by FDA, 2004 to 2015  
 
Source: OIG analysis of FDA data, 2016. 
 
The proportion of facilities inspected decreased despite an increase in 
spending for FDAs domestic food facility inspections.  Spending for 
FDAs domestic food facility inspections increased by 80 percent from 
about $78 million in 2004 to $140 million in 2011, the first year of FSMA 
implementation.29  It then decreased to $130 million in 2015.  See 
Exhibit 2 and Appendix C for more information on FDA spending. 
FDA officials provided several reasons for why they were not able to 
inspect more facilities with the increase in resources.  FDA officials 
explained that they are engaged in other activities to protect public health, 
such as responding to food recalls as well as collecting samples, records, 
and other evidence to identify the source of an outbreak.  They also 
explained that they needed to expend resources to attempt to inspect 
facilitiessometimes to confirm that they were out of businessto meet 
the FSMA mandates.30   
 
 
                        ____________________________________________________________ 
29 Spending also increased in 2009 and 2010, 2 years prior to FSMA. 
30 Additionally, FDA officials explained that the same investigators conducted 
inspections of both foreign and domestic facilities, which may be another reason for not 
being able to inspect more domestic food facilities.  According to FDA, foreign food 
facility inspections increased from 994 in 2011 to 1,363 in 2015. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     11 
 
 
   
   
Exhibit 2: FDA Spending for Domestic Food Facility Inspections, 2004 to 
2015*  
 
Source: OIG analysis of FDA data, 2016. 
*Spending is in 2015 dollars. 
 
FDA did not always take action to ensure that 
facilities corrected significant inspection violations 
When FDA uncovers significant inspection violations and assigns an OAI 
classification, an advisory action or enforcement action is warranted.  This 
ensures that the food handled by these facilities is safe and helps to 
prevent future outbreaks of foodborne illness.     
FDA uncovered significant inspection violations in 1 to 2 
percent of facilities inspected each year 
FDA identified a total of 1,245 facilities that had significant inspection 
violations found during 1,535 OAI classified inspections from 2011 to 
2015.  FDA often classified inspections as OAI because investigators 
identified unsafe manufacturing and handling practices as well as 
unsanitary conditions.31  See the text box for examples.   
 
 
                        ____________________________________________________________ 
31 This is based on a review of FDAs inspection reports from 2011, which was the most 
complete year of reports available. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     12 
 
 
   
   
Examples of Significant Inspection Violations 
 
FDA found unsanitary conditions in a New Mexico facility that 
manufactures chili peppers and spices.  FDA investigators took 
environmental samples at the facility, and 21 came back positive for 
Salmonella. The strain of Salmonella uncovered in this inspection was 
identical to the strain discovered in the plant during a previous 
inspection. 
 
FDA found unsanitary conditions inside a tofu manufacturing facility in 
Washington.  Among the agencys concerns were live birds and 
insects in production areas, mishandling of fresh tofu, and evidence of 
both live and dead rodents in the packaging room.  In addition, FDA 
also uncovered a long list of labeling errors. 
 
FDA found unsanitary conditions inside a cheese processing plant in 
Kentucky.  FDA investigators found live and dead pests throughout the 
facility and an employee stirring cheese curds with bare hands.  FDA 
investigators took environmental samples at the facility and 29 came 
back positive for Listeria monocytogenes.   
 
 
FDA often took no action in response to significant inspection 
violations 
FDA took no advisory or enforcement action in response to 22 percent of 
the significant inspection violations from 2011 to 2015.32  If FDA takes no 
action in such cases, facilities may not correct the violations; this 
undermines FDAs efforts to ensure that the food supply is safe. 
 
When FDA did take action, it most commonly relied 
on facilities to voluntarily correct significant 
inspection violations; these actions were not always 
timely nor did they always result in the correction of 
these violations 
FDA most commonly initiated advisory actions in response to the 
significant inspection violations from 2011 to 2015.  These actions 
included warning letters, untitled letters, or regulatory meetings.  These 
                        ____________________________________________________________ 
32 A regulatory actioneither an advisory action or an enforcement actionis warranted 
in response to significant inspection violations found during an inspection classified as 
OAI.  FDA also expects to conduct a followup inspection in response to significant 
inspection violations, but these are not regulatory actions.  See analysis on page 16. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     13 
 
 
   
   
actions communicate to the facility that FDA is aware of their violations 
and requests that the facility voluntarily correct them.  See Exhibit 3.  
Exhibit 3: Actions Taken by FDA in Response to Significant Inspection 
Violations, 2011 to 2015 
No Action
Advisory  22%
Action
73%
ENFORCEMENT ACTIONS*
Judicial 
4%
Administrative
N = 1,535 1%
 
Source: OIG analysis of FDA data 2016. 
* In eight instances, FDA took an enforcement action in addition to an advisory action. 
 
  
In contrast, FDA less frequently initiated enforcement actions in response 
to significant inspection violations.  Enforcement actions require 
compliance and include judicial actions and administrative actions.  
Specifically, FDA initiated judicial actions such as seizures or injunctions 
in response to 4 percent of the significant inspection violations.  FDA 
initiated administrative actions such as the detention of food products or 
suspension of a facilitys registration in response to only 1 percent of the 
significant inspection violations.   
Further, FDA rarely took advantage of the new actions provided by 
FSMA.  As discussed above, FSMA provided FDA with several new 
administrative tools to allow the agency to take action by itself to correct 
violations.  Most notably, FSMA eased the criteria for administratively 
detaining potentially unsafe food, provided FDA with authority to mandate 
the recall of certain foods, and allowed FDA to suspend the registration of 
a facility and prohibit that facility from distributing food.33  However, 
                        ____________________________________________________________ 
33 Section 306 of the FSMA also amended section 807 of the FD&C Act (21 U.S.C. 
384c(b)) and authorized FDA to refuse admission of food products into the United States 
if they are from a foreign facility that refuses to allow FDA investigators to enter. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     14 
 
 
   
   
FDA rarely used these tools in response to significant inspection 
violations.34  From 2011 to 2015, FDA issued an administrative detention 
order in five instances and twice suspended facility registrations.  
Additionally, from 2011 to 2015 it had not initiated any mandatory recalls 
in response to significant inspection violations.35 
FDAs actions were not always timely, allowing facilities to 
continue to operate under conditions that may threaten public 
health  
In some cases, FDA took a long time to take an action in response to 
significant inspection violations found during an inspection classified as 
OAI.  During this time, these facilities may have continued to operate 
under conditions that areharmful to public health. 
 
Notably, FDAs goal is to issue all warning letters within 4 months of the 
end of the inspection or the return of a positive test sample.36  However, 
from 2011 to 2015 FDA issued almost half of all warning letters after the 
expected timeframe.  Even more concerning, it took FDA more than 6 
months to issue 20 percent of all warning letters; 2 percent were issued 
more than a year after the inspection (see Exhibit 4).  When warning 
letters are delayed, the facility may continue to manufacture food under 
potentially unsafe or unsanitary conditionsfood that could then reach 
store shelves and restaurants.   
   
                        ____________________________________________________________ 
34 There are statutorily established risk-level criteria associated with FDAs ability to 
suspend a facility registration (FD&C Act  415(b)) and to issue an administrative 
detention order (FD&C Act  304(h)(1)(A)). 
35 FDA has used mandatory recall twice in other circumstances unrelated to facility 
inspections.  The first time was in February 2013 to contain pet food adulterated with 
Salmonella, and the second time was in November 2013 to address concerns about a 
dietary supplement containing a new ingredient. 
36 FDA, Regulatory Procedures Manual, ch. 4,  4-1-1, Exhibit 4-1, Procedures for 
Clearing FDA Warning Letters and Untitled Letters.  Accessed at http://www.fda.gov/ 
downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM176965.pdf 
on October 17, 2016. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     15 
 
 
   
   
Exhibit 4: Time It Took FDA to Issue Warning Letters, 2011-2015 
Within 4 Months
51%
7 Months to 1 
5 Months
Year
17%
18%
6 Months
11%
Greater than 1 
Year...
 
Source: OIG analysis of FDA data 2016. 
Note: Percentages do not equal 100 percent due to rounding. 
 
Facilities may also continue to operate under potentially unsafe conditions 
while FDA initiates other types of action.  On average, FDA took 6.7 
months to initiate a judicial action, 4.5 months to initiate an advisory 
action, and 2.8 months to initiate an administrative action.37  In some 
cases, FDA took more than a year to take an action.  In one example, FDA 
took 1.7 years to issue an untitled letter.  In other examples, FDA took 1.1 
years for a seizure and almost 2 years for an injunction.38  Prompt action 
by FDA in response to significant inspection violations is an important 
safeguard of the food supply and is essential to preventing outbreaks of 
foodborne illness.  See Appendix D for the length of time it took FDA to 
take action in response to significant inspection violations. 
 
FDAs actions that relied on voluntary compliance did not 
always result in facilities correcting violations 
When FDA relied on advisory actionssuch as issuing warning letters
facilities did not always correct the problems.  For example, FDA cited 
one facility for preparing its food under unsanitary conditions.  FDA 
observed rainwater leaking through the roof, directly above where food 
was being prepared, as well as cracks and holes in the walls and floor that 
prohibited adequate cleaning.  The inspection revealed the presence of 
                        ____________________________________________________________ 
37 In seven instances, FDA initiated suspension of registration and administrative 
detention; it conducted these actions in a more timely manner.  See Appendix D. 
38 We recognize that FDAs actions may be delayed, for example, by disputes over the 
lawfulness of a product. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     16 
 
 
   
   
Listeria monocytogenes in the facility, a dangerous pathogen that can 
cause life-threatening illness.  Soon after the inspection, FDA issued a 
warning letter to the facility requesting prompt correction of the 
violations; however, these violations went uncorrected over the next 2 
years.  Three subsequent inspections documented that the facility did not 
correct the violations, and FDA continued to find unsanitary conditions 
and the presence of Listeria monocytogenes.  
 
This facility was not unique.  A number of facilities continued to be in 
violation after FDA took an advisory action.  Of the 766 facilities that 
received advisory actions in which FDA conducted a followup inspection, 
about one in five facilities were cited as having significant inspection 
violations, resulting in a second OAI classification.  In about three-
quarters of these facilities, FDA investigators found violations identical to 
those in the previous inspection. If FDA does not take swift and effective 
 
action to ensure that all violations are corrected, it is unable to guarantee 
that the food handled by these facilities is safe and free of disease-causing 
organisms, chemicals, or other harmful substances.  
 
FDA did not consistently conduct timely followup 
inspections to ensure that facilities had corrected 
significant inspection violations  
FDA is expected to conduct followup inspections of facilities with 
significant inspection violations to verify that the facility has corrected the 
violations and to ensure that the 
facility does not have any new 
Of the significant inspection 
violations.  Appropriate and  violations: 
timely followup inspections help   
to ensure prompt compliance and  17%  had no followup 
inspection at all 
limit the threat of potentially 
 
harmful products entering the 
had no followup 
31% 
U.S. food supply.  inspection within 1 
year 
For almost half of the significant 
inspection violations from 2011 
to 2015, FDA did not conduct a timely followup inspectionan 
inspection within 1 yearto ensure that the facility had corrected the 
problem.  For 17 percent of the significant inspection violations, FDA did 
not conduct a followup inspection of the facility at all.  For another 
31 percent of these significant inspection violations, FDA did not conduct 
a timely followup inspection of the facility.  For 5 percent, FDA took 
multiple years to conduct a followup inspection.  If FDA does not ensure 
that significant inspection violations are corrected in a timely manner, it is 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     17 
 
 
   
   
unable to guarantee that these facilities are not producing and distributing 
food that is harmful to the public (see Exhibit 5).   
Exhibit 5: Time It Took FDA to Conduct Followup Inspections of Significant 
Inspection Violations, 2011 to 2015  
Timely followup 
within 6 months
No followup 
at all 11%
17%
No followup 
within 1 year Timely followup in 
31% 6 months to 1 year
40%
N = 1,497*
 
.  
Source: OIG analysis of FDA data, 2016
* We excluded 38 significant inspection violations because FDA did not have at least 1 year from the 
inspection date to conduct a followup inspection. 
   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     18 
 
 
   
   
CONCLUSION AND RECOMMENDATIONS 
The goal of FSMA is to prevent food safety problems rather than react to 
them.  To that end, FSMA requires FDA to inspect domestic food facilities 
within certain timeframes, with high-risk facilities requiring more frequent 
inspection.  It also provides FDA with new enforcement authorities 
designed to achieve higher rates of compliance and better respond to 
problems when they occur.   
We found that FDA is on track to meet the inspection timeframes mandated 
by FSMA for the initial inspection cycles.  Shortened timeframes in which to 
complete required inspections, inaccurate data that results in numerous 
attempted inspections, and the lack of a policy to reschedule attempted 
inspections could affect FDAs ability to meet FSMA mandates in the future.   
Further, although FDA is on track to meet the FSMA inspection mandates, 
this did not result in a greater number of facilities being inspected.  In fact, 
the overall number of food facilities FDA inspectedexcluding the number 
of facilities that it attempted to inspectdecreased over time.   
In addition, FDA did not always take action when it uncovered significant 
inspection violations that potentially threaten the safety of the food supply.  
When it did take action, it most commonly relied on facilities to voluntarily 
correct the violations.  Also, it rarely took advantage of the new 
administrative actions provided by FSMA.  Moreover, FDAs advisory and 
enforcement actions were not always timely nor did they always result in the 
correction of the violations.  Further, FDA did not consistently conduct 
timely followup inspections to ensure that facilities corrected the violations.   
Overall, the findings show that FDA did not always take swift and effective 
action to ensure that significant inspection violations were corrected; more 
needs to be done to protect our food supply.  If FDA does not routinely 
inspect food facilities and ensure that violations are remedied, it is unable to 
ensure that these facilities are complying with applicable laws and 
regulations and that the food handled by these facilities is safe.   
We recommend that FDA take the following measures.  
Improve how it handles attempted inspections to ensure better 
use of resources  
FDA should take additional steps to improve the accuracy of its information 
about facilities requiring inspection.  Specifically, it should identify facilities 
that do not need to be inspected because they are out of business and remove 
them from its list of facilities to inspect.  It should also improve the details of 
these lists to indicate when temporarily closed facilities are open so that 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     19 
 
 
   
   
future inspections can occur.  This will allow FDA to decrease the number of 
attempted inspections each year and use its resources more efficiently.  
FDA should also develop a policy that requires FDA to rescheduleon a 
timely basisattempted inspections of facilities that are seasonal or 
temporarily inactive so that these facilities are inspected.   
Take appropriate action against all facilities with significant 
inspection violations 
In our previous report, we recommended that FDA take appropriate action 
against all facilities that have violations found during an OAI classified 
inspection.  We continue to recommend that FDA take the most effective 
action to achieve compliance and to take administrative or judicial actions 
against facilities that do not voluntarily comply.  FDA should also 
consider using more frequently the new administrative tools provided by 
FSMA.   
Improve the timeliness of FDAs actions, including warning 
letters, so that facilities do not continue to operate under 
harmful conditions 
FDAs advisory and enforcement actions were not always timely and 
allowed facilities to continue to operate under conditions that may threaten 
public health.  FDA should initiate regulatory actions promptly in 
response to facilities with significant inspection violations found during an 
OAI classified inspection.  This should include issuing warning letters in a 
timely manner.  
Conduct timely followup inspections to ensure that significant 
inspection violations are corrected 
In our previous report, we recommended that FDA ensure that all facilities 
correct significant inspection violations found during an OAI classified 
inspection.  We continue to recommend that FDA do this, and that it 
conduct followup inspections in a timely manner to verify that facilities 
have remedied the violations.  
   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     20 
 
 
   
   
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA concurred with all four of our recommendations.   
FDA concurred with our first recommendation to improve how it handles 
attempted inspections to ensure better use of resources.  FDA noted that 
the number of attempted inspections was high during the initial inspection 
cycles but that these inspections help improve the accuracy of FDAs 
databases.  FDA noted that as it continues to inspect facilities, the data will 
become more accurate and there will be fewer attempted inspections.  
FDA also stated that it is revising its procedures to address attempted 
inspections for seasonal or inactive facilities.  Immediately after an 
attempted inspection of these facilities, FDA will establish a date to 
reschedule an inspection.  
FDA concurred with our second recommendation to take appropriate 
action against all facilities with significant inspection violations.  FDA 
stated that to monitor facilities that warrant followup, it developed a report 
that can display Official Action Indicated (OAI) inspection classifications 
and the resulting regulatory action(s) and activities that were taken or 
conducted.  FDA noted that the relevant office can use the report to more 
efficiently track compliance activities resulting from OAI inspections for 
which it is responsible. 
FDA concurred with our third recommendation to improve the timeliness 
of its actions, including warning letters.  FDA indicated that it strives to 
take advisory and enforcement actions in a timely manner and that it is 
particularly focused on those scenarios that may involve immediate risk to 
public health.  FDA also stated that it has taken steps to support timely 
advisory actions, including direct reference authority to district offices for 
certain violations.  Direct reference is a business process whereby field 
offices may initiate regulatory actions without prior review by the Center 
or Office of Chief Counsel.  FDA added that it will continue to examine its 
regulatory program for further activities to increase operational 
efficiencies. 
FDA concurred with our fourth recommendation to conduct timely 
followup inspections to ensure that significant inspection violations are 
corrected.  FDA stated that it is developing a system that will track 
activities or information relating to each specific inspection violation to 
ensure that all violations are corrected for all facilities that receive OAI 
classifications.  It also developed a procedure to track OAI inspections and 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     21 
 
 
   
   
followup inspections, and it created an oversight group for food-related 
cases that has enhanced the oversight of violative food facilities. 
OIG appreciates FDAs commitment to its public health mission and its 
efforts to improve its performance of domestic food facility 
inspections.  We value the steps FDA is taking to address the 
recommendations and look forward to FDA providing more information in 
its Final Management Decision.  In particular, we appreciate FDA creating 
new procedures for establishing a reschedule date for facilities it attempted 
to inspect and a tracking system to monitor facilities that warrant further 
action.  We look forward to FDA providing additional information about 
how these steps have reduced the number of attempted inspections in 
future cycles.  We also look forward to FDA providing additional 
information about how these steps help it ensure that it takes appropriate 
action and conducts timely followup inspections of all significant 
inspection violations. 
For the full text of FDAs comments, see Appendix E.  
 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     22 
 
 
   
   
APPENDIX A: DETAILED METHODOLOGY 
Analysis of Whether FDA Is On Track to Meet the Inspection 
Timeframes Mandated by FSMA  
To assess whether FDA is on track to inspect domestic food facilities at the 
frequency mandated by FSMA, we requested the list of high-risk and non-
high-risk facilities that FDA identified as requiring inspection during the 
initial inspection cycles.39  In 2011, FDA created a list of all facilities subject 
to FDA inspection and designated each facility as high risk or non-high risk.  
FDA was required to inspect (1) all high-risk facilities within the 5-year 
period, from 2011 to 2015, and (2) all non-high-risk facilities within the 7-
year period, from 2011 to 2017.40 
We also requested from FDA data about inspections of food facilities from 
its Field Accomplishments and Compliance Tracking System (FACTS) for 
each year from 2009 to 2015.  Using FACTS data, we calculated the number 
of all high-risk and non-high-risk facilities that FDA inspected from the 
high-risk list and from the non-high-risk list for the initial inspection cycles.  
We analyzed the number of unique facilities that FDA inspectedor 
attempted to inspectto determine whether FDA was on track to meet the 
inspection mandates.  Attempted inspections occur when an investigator 
visits a facility but it is either out of business or otherwise not in operation.  
FDA counts facilities that it attempted to inspect toward meeting the 
inspection mandates.   
Changes in the Overall Number of Domestic Food Facilities 
Inspected by FDA and Spending  
Next, we determined whether the FSMA inspection mandates changed the 
overall number of domestic food facilities that FDA inspected each year.  To 
do this, we requested from FDA the total number of domestic food facilities 
known to be under FDA jurisdiction for each year from 2009 to 2015.41  
This information is from FDAs Official Establishment Inventory.  
We used FACTS to determine the total number of domestic facilities that 
FDA inspected each year.  This analysis includes only facilities that were 
actually inspected; it does not include facilities that FDA attempted to 
inspect.  We then calculated the proportion of all domestic food facilities 
                        ____________________________________________________________ 
39 The number of non-high-risk facilities includes 51,158 facilities that were identified in 
2011 and an additional 9,852 facilities that were added to the list in 2014.  FDA indicated 
that all of these facilities were to be inspected by the end of the first inspection cycle. 
40 All years presented in the report are fiscal years. 
41 We used data that we collected from FDA from 2004 to 2008 for our prior study.  See 
OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), April 2010. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     23 
 
 
   
   
that FDA inspected each year since 2009 and noted any changes since 2011, 
when FSMA was implemented. 
Additionally, we requested FDAs appropriations for each year from 2004 
to 2015.  We specifically asked for the total amount spent on domestic 
food facility inspections, including the amount for inspections conducted 
under State contracts on behalf of FDA.  We adjusted all spending to 2015 
dollars.42   
There are several key differences between the analysis that determines 
whether FDA is likely to meet the inspection mandates and the analysis 
that determines the number of facilities under FDAs jurisdiction that were 
actually inspected each year.  The analysis of whether FDA is on track to 
meet the inspection mandates is based on a list of facilities that are subject 
to the inspection timeframes mandated by FSMA.43  This list does not 
include certain types of facilities, such as certain food brokers, that are not 
subject to the FSMA inspection mandates.44  It also does not include 
facilities that came into the business after FDA created these lists.  
Another reason these two analyses differ is that the number of facilities 
inspected are counted differently.  For the analysis of the inspection mandates, 
we followed FDAs method for counting whether it met the mandates.  
Specifically, we counted the number of unique facilities that FDA inspected
or attempted to inspectduring the inspection cycle. In contrast, for the 
analysis that determines the number of facilities inspected each year, we 
included only facilities that FDA actually inspected, not attempted to inspect.  
This allowed us to understand the overall coverage of the number and 
proportion of facilities in the food supply that FDA inspects each year.  Further, 
                        ____________________________________________________________ 
42 To adjust spending to 2015 dollars, we used the U.S. Department of Commerce Bureau 
of Economic Analysis Implicit Price Deflator for Gross Domestic Product.  Accessed at 
http://www.bea.gov on October 17, 2016. 
43 To compile this list FDA relied on information from its Official Establishment 
Inventory and incorporated supplemental information from the Bioterrorism Registry as 
of June 2011.  Section 301 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) directed FDA to create a registry of 
food facilities to protect the public from a threatened or actual terrorist attack on the U.S. 
food supply and other food-related emergencies.  FSMA directed FDA to use the registry 
to identify food facilities subject to inspection.  However, the registry included a number 
of facilities that were either not under FDAs jurisdiction or were not subject to the 
inspection mandates.  We excluded from our calculations all facilities that FDA 
determined were not required to be inspected under FSMA. 
44 A food broker is an independent sales agent that negotiates sales for both food 
producers and food buyers, sometimes without taking possession of any products. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     24 
 
 
   
   
if a facility was inspected in multiple years, we counted the facility each year 
that it was inspected.45   
Analysis of FDA Actions and Followup Inspections 
We determined the extent to which FDA identified and took action in 
response to the significant inspection violations.  For the purposes of this 
report, we use significant inspection violations to reflect the conditions 
found during a food facility inspection that FDA classified as OAI.  First, 
we analyzed FACTS data from 2011 to 2015 to identify the domestic 
facilities that had an inspection that FDA classified as OAI.  We 
determined that 1,245 facilities had significant inspection violations found 
during 1,535 OAI classified inspections.  Additionally, to describe the 
nature and frequency of these conditions or practices, we reviewed the 
inspection reports for 2011, which was the most complete year of reports 
available at the time of our review. 
We then requested information from FDA about any advisory or 
enforcement actions it took in response to these significant inspection 
violations found during the 1,535 OAI classified inspections, such as 
warning letters, regulatory meetings, or seizures.46  We determined how 
often FDA initiated an advisory or enforcement action to respond to 
significant inspection violations.47  We also determined how often FDA 
used administrative actions provided by FSMA, namely, administrative 
detention, suspension of facility registration, and mandatory food recalls. 
Next, we calculated the average number of months for FDA to initiate an 
action in response to significant inspection violations.48  We also 
calculated the average time it took FDA to initiate each type of action.49  
We determined the amount of time based on the number of days from the 
date the inspection ended to the date that FDA took the action.   
                        ____________________________________________________________ 
45 We are not able to determine the number of facilities that still need to be inspected 
because we cannot distinguish between facilities that are seasonal (and therefore still 
require an inspection) and facilities that went out of business.   
46 FDA provided this information from its database, the Compliance Management System 
(CMS).  This study focuses only on actions that FDA initiated; facilities may have 
initiated a voluntary recall, which is not included in this study. 
47 Our analysis includes the subsequent actions taken in response to each OAI 
classification.  In 20 instances, FDA took more than 1 action following an OAI.   
48 In this analysis, the averages were generally similar to the medians. 
49 FDA sometimes initiated one action in response to multiple violations.  In these cases, 
we calculated the time it took FDA to initiate the action in response to each of the 
violations. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     25 
 
 
   
   
Additionally, we determined the extent to which facilities corrected the 
violations in response to FDAs advisory actions.  To do this, we started 
with the 1,245 facilities that had significant inspection violations from 
2011 to 2015.  We then identified the 766 facilities for which FDA took an 
advisory action and conducted a followup inspection so that it could 
determine whether the facility had corrected the problems.  Next, we 
determined the number of these facilities that received a second, 
subsequent OAI classification after the advisory action.  We reviewed the 
inspection report for both the first inspection and the subsequent 
inspection to determine the number of facilities that had the identical 
violations in both reports.50   
Lastly, we determined the extent to which FDA conducted timely followup 
inspections.  To do this, we reviewed FDAs FACTS data for significant 
inspection violationsviolations found during inspections classified as 
OAIand determined the length of time it took FDA to conduct a 
followup inspection.51  We measured the number of days from the date the 
earlier inspection ended to the date the followup inspection ended.  We 
then determined how often FDA conducted a followup inspection within 1 
year from the date the earlier inspection ended. 
Structured Interviews with FDA Officials  
Throughout the course of the study, we conducted structured interviews 
with FDA officials to discuss the information FDA provided.  These 
interviews focused on FDAs implementation of the FSMA inspection 
mandates, its designation of a facility as high risk, how it counts 
inspections toward the mandates, and any challenges it faces 
implementing FSMA inspection requirements.   
 
                        ____________________________________________________________ 
50 Investigators identified the same violations or reported that the previous violation(s) 
was not corrected. 
51 We did not include 38 violations from this analysis because FDA did not have at least 
1 year from the inspection date to conduct a followup inspection.  However, we included 
additional data from FDA for 85 followup inspections that were conducted from October 
2015 to May 2016. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     26 
 
 
   
   
APPENDIX B 
Exhibit 1: Food Facilities Inspected by FDA, 2004 to 2015 
Number of Food 
Facilities Subject to  Number of Food  Percentage of Food 
FDA Inspection  Facilities Inspected  Facilities Inspected 
Fiscal Year 
2004 
59,305  17,032  29% 
2005 
61,930  15,773  25% 
2006 
62,929  14,547  23% 
2007 
65,520  14,339  22% 
2008 
67,819  14,966  22% 
2009 
66,196  15,920  24% 
2010 
73,930  17,609  24% 
2011 
75,990  19,369  25% 
2012 
77,672  19,176  25% 
2013 
82,401  16,846  20% 
2014 
82,280  16,287  20% 
2015 
86,032  16,135  19% 
 
Source: OIG analysis of FDA data, 2016. 
 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     27 
 
 
   
   
APPENDIX C 
Exhibit 1: FDA Spending for Domestic Food Facility Inspections, 2004 to 
2015* 
Fiscal Year  Total Spending 
2004  $77,620,360 
2005  $80,204,679 
2006  $68,846,750 
2007  $78,820,744 
2008  $89,963,823 
2009  $126,716,576 
2010  $137,487,328 
2011  $139,702,725 
2012  $129,555,357 
2013  $121,581,171 
2014  $131,992,388 
2015  $129,824,038 
Source: OIG analysis of FDA data for domestic food facility inspections, 2016.   
* Spending is in 2015 dollars. 
 
   
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     28 
 
 
   
   
APPENDIX D 
Exhibit 1: Time It Took for FDA to Take Regulatory Actions in Response to 
Significant Inspection Violations, 2011 to 2015 
Total Number 
of Actions  Average Number 
Advisory Actions  Taken  of Months 
Warning Letter  903  4.4 
Regulatory Meeting  136  4.4 
Untitled Letter  74  6.1 
Total Number 
of Actions  Average Number 
Administrative Actions  Taken  of Months 
Import Alert  12  3.2 
Suspension of Food Facility Registration  2  0.8 
Administrative Detention Order  5  0.2 
Total Number 
of Actions  Average Number 
Judicial Actions  Taken  of Months 
Injunction  37  8.9 
Seizure   21  3.1 
 
Source: OIG analysis of FDA data, 2016. 
Notes: FDA also initiated a reconditioning proposal, a post-inspection letter, and three 
emergency permit controls in response to significant inspection violations. 
FDA sometimes initiated one action in response to multiple violations.  In these cases, we 
calculated the time it took FDA to initiate the action in response to each of the violations. 
 
 
Challenges Remain in FDAs Inspections of Domestic Food Facilities (OEI-02-14-00420)     29 
 
 
   
   
APPENDIX E 
Agency Comments 
 
 
 
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ACKNOWLEDGMENTS 
Vincent Greiber served as the team leader for this study.  Others in the 
Office of Evaluation and Inspections who conducted the study include 
Marissa Baron, Jillian Husman, and Lauren Peterson.  Office of 
Evaluation and Inspections staff who provided support include Althea 
Hosein and Melicia Seay.  
This report was prepared under the direction of Jodi Nudelman, Regional 
Inspector General for Evaluation and Inspections in the New York regional 
office, and Nancy Harrison and Meridith Seife, Deputy Regional 
Inspectors General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.   
 
 
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Office of Inspector General
http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS) programs, as  well  as the health  and welfare of individuals served by those programs.  
This statutory mission is carried  out through a nationwide network of audits, investigations,  
and inspections conducted by the following operating components: 
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The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
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