Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
V   FDA
ULNERABILITIES IN  S 
 
O S F
VER SIGHT OF  TATE  OOD 
 
F I  
ACILITY  NSPECTIONS
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
December 2011 
OEI-02-09-00430   
II NN TTE RRX OOE DDC UUU CCT TTI IIVOOENN     S U M M A R Y  
OBJECTIVES 
1.  To determine the extent to which the Food and Drug Administration 
(FDA) enters into contracts with States to inspect food facilities.  
2.  To determine the extent to which FDA ensures that States complete 
the inspections required by their contracts. 
3.  To determine whether FDA ensures that State inspections are 
properly classified and violations are remedied. 
4.  To determine the extent to which FDA audits State inspections and 
addresses deficiencies identified by audits. 
BACKGROUND 
Each year, 128,000 Americans are hospitalized and 3,000 die after 
consuming contaminated foods and beverages.  FDA is responsible for 
safeguarding the Nations food supply and for routinely inspecting food 
facilities.  In addition to conducting its own inspections, FDA relies on 
State agencies to conduct inspections on its behalf; however, in recent 
years, concerns have been raised about the rigor of these State 
inspections.  For example, the peanut processing plant responsible for a 
2009 salmonella outbreak was inspected multiple times by a State 
agency working on behalf of FDA.  This outbreak resulted in one of the 
largest food recalls in U.S. history and has led to serious questions 
about the effectiveness of State food facility inspections.  Because of 
concerns about food facility inspections conducted by State agencies, 
this review was requested by the House Committee on Appropriations, 
Subcommittee on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies.   
FDA often enters into contracts with State agencies responsible for 
ensuring food safety.  Each contract includes the number of food facility 
inspections the State will conduct for FDA and the amount the State 
will be paid for each inspection.  During the 2009 contract year, FDA 
held contracts with 41 States to conduct FDAs inspections. 
FDA oversees State inspections though its Contract Inspection Audit 
Program.  The audit program is designed to verify that States conduct 
 
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E X E C U T I V E   S U M M A R Y  
inspections that satisfy the requirements of their contracts.  FDA 
requires that a minimum of 7 percent of a States contract inspections 
be audited each year.  This minimum percentagewhich is known as 
the minimum audit rateensures that States are conducting adequate 
inspections that meet the conditions of the contract.    
We based this study on several sources of data:  (1) FDAs inspection 
data, (2) FDAs documentation of contract inspections and payment 
data, (3) audit and corrective action documentation, and (4) structured 
interviews with FDA officials.  
FINDINGS 
FDA has increasingly relied on States to inspect food facilities.  
Although the number of food facilties inspected by FDA has decreased 
since 2004, the number of facilities inspected by States under contract 
to FDA has increased significantly.  In fiscal year (FY) 2009, 59 percent 
of FDAs food inspections were conducted by State inspectors, compared 
to only 42 percent in FY 2004.   
In eight States, FDA failed to ensure that the required number of 
inspections was completed; FDA paid for many inspections that 
were incomplete.  These 8 States were responsible for completing a 
total of 2,170 inspections; however, these States failed to complete  
10 percent of these inspections during the contract year.  When States 
fail to complete the inspections required in their contracts, FDAs ability 
to identify facilities with potentially serious food safety violations is 
diminished.  Also, FDA paid for 130 of the 221 inspections that were not 
completed.  In four additional States, FDA paid for inspection visits, 
even though payment for such visits was not specified in the States 
contracts.  
FDA did not ensure that all State inspections were properly 
classified and that all violations were remedied.  FDA officials 
responsible for 11 of 41 States were unclear about how to properly 
classify contract inspections.  In these 11 States, FDA officials reported 
that they would not assign official action indicated classifications to 
State inspections under any circumstances, contrary to FDA guidance.  
If FDA does not correctly classify inspections that reveal serious 
violations, its ability to assess facilities relative risk is impaired.  
Additionally, FDA officials responsible for another 11 States reported 
that when States were responsible for correcting violations, FDA was 
not always informed about actions taken by the States.  As a result, 
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E X E C U T I V E   S U M M A R Y  
FDA was unable to ensure that serious violations had been adequately 
addressed.    
FDA failed to complete the required number of audits for one-third 
of the States and did not always follow up on systemic problems 
identified.  For 14 of 41 States with contracts, FDA did not complete 
the required number of audits and therefore failed to meet its minimum 
audit rate.  Additionally, the audits in 10 States revealed systemic 
problems that needed to be corrected; however, FDA initiated corrective 
action in only 4 of the 10 States.  If FDA does not follow its guidance 
and complete the required number of audits and address systemic 
problems, it cannot verify that States are conducting suitable 
inspections that satisfy the requirements of the contracts. 
RECOMMENDATIONS 
Our report identified significant weaknesses in FDAs oversight of food 
facility inspections conducted by States.  Taken together, the findings 
demonstrate that more needs to be done to protect public health and to 
ensure that contract inspections are effective and prevent outbreaks of 
foodborne illness.  Therefore, we recommend that FDA:  
Ensure that all contract inspections are completed, properly 
documented, and appropriately paid for. 
Ensure that contract inspections are properly classified in 
accordance with FDA guidance. 
Ensure that all inspection violations are remedied by routinely 
tracking all actions taken to correct violations. 
Ensure that the minimum audit rate is met in all States. 
Address any systemic problems identified by audits. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
FDA concurred with four of our recommendations and agreed in part 
with the fifth.   
In response to our first recommendation, to ensure that all contract 
inspections are completed, properly documented, and appropriately paid 
for, FDA concurred, stating that it is conducting a systematic review of 
the State contracting program.   
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E X E C U T I V E   S U M M A R Y  
In response to our second recommendation, to ensure that contract 
inspections are properly classified, FDA concurred and noted that it is 
revising its directive to emphasize more clearly that classifications must 
be accurate, timely, and uniform.   
In response to our third recommendation, to ensure that all inspection 
violations are remedied by routinely tracking all actions taken to correct 
violations, FDA agreed to track most violative inspections and the 
remedies taken by industry.  However, FDA noted that certain 
violations may not be suitable for inspection followup and that other 
approaches may be used to track such violations.  While we appreciate 
FDAs commitment to track certain violations, we encourage it to track 
all violations, even those that do not warrant followup inspections.  FDA 
can use violation information to help establish the relative risk of 
facilities and determine how often they should be inspected. 
In response to our fourth recommendation, to ensure that the minimum 
audit rate is met in all States, FDA concurred, noting that it is 
reviewing the current reporting requirements to ensure that audits are 
completed and tracked to verify compliance with FDA requirements.   
Finally, in response to our fifth recommendation, to address any 
systemic problems identified by audits, FDA concurred and noted that it 
will continue to develop processes and procedures to ensure that 
systemic problems are identified and that corrective action plans are 
implemented. 
We support FDAs efforts to strengthen State contract inspections and 
address the issues identified in the report.  With the implementation of 
the Manufactured Food Regulatory Program Standards, FDAs 
oversight of State inspections is even more critical.  As States adopt the 
standards, it is essential that FDA strengthen not only States oversight 
but also its own oversight to ensure that States conduct high-quality 
food facility inspections. 
 
 
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 T A B L E   O F   C O N T E N T S  
 
EX E CUT I VE  SUM M ARY  .....................................i 
   
I NT RO DU CT I O N  ............................................ 1 
 
F I NDI NG S  .................................................  10 
FDA has increasingly relied on States to inspect food facilities ...  10 
In eight States, FDA failed to ensure that the required number          
of inspections was completed; FDA paid for many inspections            
that were incomplete ....................................  11 
FDA did not ensure that all State inspections were properly             
classified and that all violations were remedied.   .............  12 
FDA failed to complete the required number of audits                       
for one-third of the States and did not always follow                         
up on systemic problems identified .........................  14 
 
RECO M M END AT I O N S  .....................................  17 
Agency Comments and Office of Inspector General Response ....  19 
 
APP EN DI X ES  ............................................. 21 
  A:  Performance Factors of the Contract Audit ...............  21 
B:  States Role in Conducting Audits as Part of the                                                                       
Food and Drug Administrations Contract Inspection              
Audit Program ......................................  22 
C:  Description of Services in State Contracts for the 2009     
Contract Year .......................................  24 
  D:  Number of Inspections Classified as Official Action Indicated 
Conducted by FDA and by States, FYs 20042009  .........  25                                                                          
  E:  Audits Completed for the 2009 Contract Year, by State .....  26 
  F:  Agency Comments ...................................  27 
 
ACKNO WL E DG M E N T S .....................................  32 
 
     
     
 I N T R O D U C T I O N  
OBJECTIVES 
1. To determine the extent to which the Food and Drug 
Administration (FDA) enters into contracts with States to 
inspect food facilities. 
2. To determine the extent to which FDA ensures that States 
complete the inspections required by their contracts. 
3. To determine whether FDA ensures that State inspections are 
properly classified and violations are remedied. 
4. To determine the extent to which FDA audits State inspections 
and addresses deficiencies identified by audits. 
BACKGROUND 
Each year, 128,000 Americans are hospitalized and 3,000 die after 
consuming contaminated foods and beverages.1  FDA is 
responsible for safeguarding the Nations food supply and for 
routinely inspecting food facilities.  In addition to conducting its 
own inspections, FDA relies on State agencies to conduct 
inspections on its behalf; however, in recent years, concerns have 
been raised about the rigor of these State inspections.  For 
example, the peanut processing plant responsible for a  
2009 salmonella outbreak was inspected multiple times by a State 
agency working on behalf of FDA.2  This outbreak resulted in one 
of the largest food recalls in U.S. history and has led to serious 
questions about the effectiveness of State food facility inspections.    
The FDA Food Safety Modernization Act was enacted in January 
2011.  This Act substantially increases the number of annual 
inspections that FDA will need to complete; it also authorizes FDA 
to continue its reliance upon State agencies to complete these 
additional inspections.3   
 
1 Elaine Scallan et al., Foodborne Illness Acquired in the United States
Unspecified Agents, Emerging Infectious Diseases, Vol. 17, No. 1, January 2011.  
Accessed at http://www.cdc.gov on January 28, 2011. 
2 FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint 
Media Teleconference, January 28, 2009.  Accessed at http://www.fda.gov  on  
January 28, 2011. 
3 P.L. 111-353. 
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I N T R O D U C T I O N  
Because of concerns about food facility inspections conducted by 
State agencies, the House Committee on Appropriations, 
Subcommittee on Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies requested that the Office of 
Inspector General (OIG) review FDAs oversight of the program.  
Among other things, the Committee was concerned about State 
inspections conducted under contract with FDA, as well as FDAs 
audits of these inspections.   
FDAs State Inspection Contracts 
FDA often enters into contracts with State agencies responsible for 
ensuring food safety.  Each contract specifies the number of food 
facility inspections the State will conduct for FDA; the amount the 
State will be paid for each inspection; and the extent to which the 
State will be paid for other activities, such as travel and training.  
In addition, each contract should specify whether the State will be 
compensated for inspection visits.  An inspection visit occurs when 
an inspector visits a food facility in an attempt to conduct an 
inspection, but the inspection cannot be completed.4   
During the 2009 contract year, FDA held contracts with 41 States 
to conduct FDAs inspections.5  In the remaining States, FDA 
conducted all of its inspections without any State assistance.  For 
the 2009 fiscal year (FY), FDA spent over $8 million for State 
contract inspections.   
Officials from FDAs 19 district offices have the primary 
responsibility for overseeing contract inspections.  These officials 
work with the States to determine which facilities will be 
inspected by FDA and which will be inspected by the States on 
FDAs behalf.6  These officials, in conjunction with certain 
contracting officials in FDA headquarters, are also responsible for 
ensuring that States have completed the required number of 
 
4 This generally occurs when a facility is out of business or no longer subject to FDA 
inspection.  A facility may no longer be subject to FDA inspection if, for example, it 
stops engaging in interstate commerce or if it is a seasonal facility that is not in 
operation at the time of the inspection visit.   
5 FDA has a contract with Puerto Rico to conduct food facility inspections.  In this 
report, we refer to Puerto Rico as a State.  In two instances, FDA had contracts with 
two agencies in a State (the Departments of Health and Agriculture).  We used the 
information from both contracts in our analysis of these States.   
6 In some cases, both FDA and the State may inspect the same facility during the 
FY.  
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I N T R O D U C T I O N  
inspections, that all inspections are properly documented, and that 
States are appropriately paid for completed inspections.7  
For each inspection, the State documents its findings in an 
inspection report and submits this report to FDA within 30 days of 
the inspection.8  Each report is entered into a database that 
houses information about all FDA inspections.  FDA then reviews 
and approves the information in this database.  Additionally, 
States must submit a quarterly invoice that lists all inspections 
completed during the previous 90 days.9 
Identifying Inspection Violations 
During an inspection, State inspectors may identify potential 
violations of food safety laws and regulations.  These violations are 
recorded in the inspection report.  Based on the inspection report, 
FDA generally assigns one of three classifications:  official action 
indicated (OAI), voluntary action indicated (VAI), or no action 
indicated (NAI).10  An OAI classification signifies that the 
inspector found objectionable conditions in the food facility and 
that these violations potentially warrant regulatory action.11  
This type of violation is the most significant identified by 
inspectors.  A VAI classification signifies that the inspector found 
violations that are serious enough to record but do not cross the 
threshold for regulatory action.12  An NAI classification signifies 
that the inspector found either no violations of law and regulations 
or violations that were so insignificant that no action is 
warranted.13   
In addition, under certain circumstances, FDA may also classify 
an inspection as referred to State (RTS).  According to FDA 
guidance, an RTS classification signifies that there is either no 
 
7 FDA, 2009 Request for Proposals:  Food,  C-1(G)(68). 
8 Ibid.,  C-1(G)(6). 
9 Ibid.,  F-1(G)(5). 
10 FDA, Office of Regulatory Affairs, Field Management Directive No. 86:  
Establishment Inspection Report Conclusions and Decisions (rev. June 7, 2007).  
Accessed at http://www.fda.gov on January 28, 2011. 
11 Ibid.  Regulatory actions include warning letters, injunctions, and seizures.   
12 Ibid. 
13 More information about inspection violations can be found in OIG, FDA 
Inspections of Domestic Food Facilities, OEI-02-08-00080, April 2010. 
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I N T R O D U C T I O N  
 
Federal jurisdiction over the violation in question or that State 
action is the most efficient method of obtaining compliance.14 
FDAs Contract Inspection Audit Program 
FDA oversees State inspections though its Contract Inspection 
Audit Program, which is designed to verify that the State 
conducts suitable inspections that satisfy the requirements 
contained in a contract.15  FDA guidance requires that a 
minimum of 7 percent of a States contract inspections be audited 
each year.  This minimum percentagewhich is known as the 
minimum audit rateensures that States are conducting 
adequate inspections that meet the conditions of the contract.16    
To perform these audits, an auditor accompanies a State inspector 
who is conducting a contract inspection.  Although most audits are 
conducted by FDA auditors, under certain circumstances, States 
may choose to assume responsibility for auditing their own 
inspectors.  The auditor observes and assesses the inspectors 
performance according to at least 18 performance factors and rates 
each as either acceptable or needing improvement.  See  
Appendix A for a description of these performance factors.  Based 
on the total number of deficiencies, the inspector is assigned an 
overall rating of either acceptable or needing improvement.  
According to FDA guidance, State inspectors who receive an 
overall rating of needing improvement should receive remedial 
training from either FDA or the State to address the deficiencies 
prior to resuming their inspection duties.17    
These audits are also used to identify systemic problems in States 
inspection programs.  According to FDA guidance, a systemic 
problem exists when audits identify the same deficiency in 
multiple audits during the same contract year.18  FDA uses the 
 
14 FDA, Office of Regulatory Affairs, Field Management Directive No. 86:  
Establishment Inspection Report Conclusions and Decisions (rev. June 7, 2007).  
Accessed at http://www.fda.gov on January 28, 2011. 
15 FDA, Office of Regulatory Affairs, Field Management Directive No. 76:    III.B. 
Accessed at http://www.fda.gov on January 28, 2011. 
16 According to its guidance, FDA may lower the minimum audit rate upon request 
from the district office.  See Field Management Directive No. 76:    III.B.  Accessed 
at http://www.fda.gov on January 28, 2011. 
17 Ibid.,  III.F. 
18 Ibid. 
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I N T R O D U C T I O N  
threshold of four or more audits to determine whether a specific 
aspect of a States inspection program needs improvement.19  A 
systemic problem also exists when 20 percent of the performance 
factors in a State are rated as needing improvement.20  
When systemic problems are identified, FDA and the State should 
determine the possible causes and solutions and agree on the type 
of corrective actions that may be needed.  According to its 
guidance, FDA must monitor the effectiveness of the corrective 
actions.21  If the deficiencies are not corrected in a reasonable 
amount of time or if they affect a substantial portion of the States 
work, FDA may recommend probation, nonextension, or 
termination of the contract.22 
During the 2009 contract year, FDA was responsible for 
conducting all of the audits in 27 States.  Ten States were 
responsible for conducting all of their audits, and four States were 
in the process of assuming responsibility for conducting their 
audits.23  See Appendix B for more detailed information about the 
States role in conducting audits. 
Manufactured Food Regulatory Program Standards  
In May 2007, FDA implemented the Manufactured Food 
Regulatory Program Standards.  These optional standards are 
designed to improve States food safety programs and to develop 
greater consistency across State inspection programs.  The 
standards address a wide range of initiatives designed to improve 
the overall quality of State inspection programs, such as 
developing appropriate protocols for food inspections and 
instituting a standard training curriculum for inspectors.  These 
standards apply to a States entire food safety program and are not 
limited to inspections conducted under contract with FDA.  For the 
2009 contract year, 21 States agreed to implement these 
 
19 FDA, 2009 Request for Proposals:  Food,  C-1(G)(5). 
20 See Field Management Directive No. 76,   III.E 
21 FDA Office of Regulatory Affairs, Field Management Directive No. 76,                   
 II.F(6).  Accessed at http://www.fda.gov on January 28, 2011. 
22 Ibid. 
23 Note that although these four States conducted some audits for training purposes, 
FDA was ultimately responsible for meeting the minimum audit rate in these States.  
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I N T R O D U C T I O N  
 
standards; all of these States were in the early stages of 
implementation.24   
Related Work 
This report builds upon a June 2000 OIG report that assessed 
FDAs oversight of State inspection contracts.  That report found 
that FDA faced significant barriers in overseeing State 
inspections, including limited training provided by FDA to State 
inspectors and limited agency expertise in providing contract 
oversight.25 In response to the report, FDA developed its Contract 
Inspection Audit Program.   
OIG has also completed a number of other studies evaluating 
FDAs role in ensuring food safety.  In a 2010 report evaluating 
FDAs inspections of domestic food facilities, OIG found that more 
than half of all food facilities have gone 5 or more years without an 
FDA inspection and that FDA does not always take swift and 
effective action to remedy violations found during inspections.26  In 
a 2009 report on food traceability, OIG found that only 5 of 40 
selected food products could be traced through each stage of the 
food supply chain.27  It also found that 59 percent of selected food 
facilities did not comply with FDAs recordkeeping requirements 
and that these requirements were not sufficient to ensure the 
traceability of the food supply.  OIG also issued a report that found 
that 5 percent of selected facilities failed to register with FDA as 
required and that almost half of the selected facilities failed to 
provide FDA with accurate information about their facilities.28  
 
24 An additional three States agreed to implement these standards, but not as part 
of their contracts with FDA. 
25 OIG, FDA Oversight:  A Call for Greater Accountability, OEI-01-98-00400,      
June 2000. 
26 OIG, FDA Inspections of Domestic Food Facilities, OEI-02-08-00080, April 2010. 
27 OIG, Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009. 
28 OIG, FDAs Food Facility Registry, OEI-02-08-00060, December 2009. 
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I N T R O D U C T I O N  
 
METHODOLOGY 
Scope  
This study assesses FDAs oversight of State food facility 
inspections.  It focuses on contract inspections and audits 
completed during the 2009 contract year; it does not include 
inspections conducted by States on their own behalf.29   
Analysis of FDAs Inspection Data  
We requested and reviewed data from FDA on all food facility 
inspections for FYs 2004 through 2009 from its inspections 
database, called the Field Accomplishments and Compliance 
Tracking System (FACTS).  FACTS includes information about all 
FDA inspections conducted by FDA and by States under contract 
with FDA, as well as the classifications of each inspection.  We 
analyzed these data to determine the number of facilities 
inspected each year.    
Analysis of State Contract Inspections and Payment Data 
We requested from FDA all contracts for the 41 States conducting 
food facility inspections on FDAs behalf.30  Specifically, we 
requested and reviewed the contracts for the 1-year contract 
period ending in 2009.31  These contracts started at different times 
during 2008.  In this study, we refer to this period as the  
2009 contract year.  We also requested and reviewed information 
about any changes made to the contracts, including any 
extensions.32   
Based on our review of the contracts, we determined the total 
number of inspections that each State was required to conduct.  
We also determined whether inspection visits were allowable 
 
29 In addition to entering into contracts, FDA has partnership agreements with 
some States.  These partnership agreements allow States and FDA to share 
information about inspections they conduct.  We did not evaluate any partnership 
agreements, as these inspections are conducted by States on their own behalf. 
30 In two instances, FDA had contracts with two agencies in a State (the 
Departments of Health and Agriculture).  We used the information from both 
contracts in our analysis of these States.   
31 We chose to use contracts ending in 2009 because it was the contract year most 
recently completed when we started this study.   
32 Three States contracts were extended beyond the contract year through an 
agreement with FDA headquarters. 
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I N T R O D U C T I O N  
 
under the contract and, therefore, should have been counted 
toward the total number of required inspections.  
To determine how many contract inspections were completed in 
the 2009 contract year, we obtained data from several sources.  
First, we analyzed FACTS to determine the total number of 
inspections recorded for each State.  Next, we asked each FDA 
district office to provide us with documentation about any 
additional inspections or inspection visits completed by the State 
but not entered into FACTS.  Using information in FACTS along 
with any additional FDA documentation provided, we determined 
how many inspections were completed by each State.   
Lastly, we requested and reviewed information from FDA about 
the total number of inspections FDA paid for in each State.  We 
used these data to determine whether FDA inappropriately paid 
for any inspections that were not completed.   
Analysis of Audit and Corrective Action Documentation  
We requested from FDA documentation of all audits conducted 
during the contract year.  We analyzed this documentation to 
determine how many audits were conducted in each State and 
whether the required number of audits was completed.33  To 
determine the required number of audits, we calculated the 
minimum audit rate.34  We took into account any instances in 
which FDA had requested a lowered audit rate for a State.  
We then reviewed the audits to determine the extent to which 
individual State inspectors had deficiencies and States had 
systemic problems.  We considered an inspector to have a 
deficiency if he or she received a rating of needing improvement in 
at least one performance factor.  We considered a State to have a 
systemic problem when the same performance factor was rated as 
needing improvement in four or more audits or when 20 percent or 
more of the performance factors in all audits in the State were 
rated as needing improvement.  We then reviewed the audits to 
 
33 FDA provided joint inspection documentation as part of its audit documentation.  
A joint inspection by FDA and the State may count as an audit if it is used for 
training purposes.  Joint inspections do not include inspector performance factors 
and generally do not include an overall rating.  
34 If the number of audits required was not a whole number, we rounded down to 
the nearest whole number.   
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I N T R O D U C T I O N  
 
determine the performance factors most frequently rated as 
needing improvement and the nature of these deficiencies.   
We also requested and reviewed documentation from FDA on any 
actions taken by FDA or the States to correct deficiencies 
identified in the audits.  We analyzed this information to 
determine the extent to which FDA followed up on problems 
identified by the audits. 
Structured Interviews With FDA Officials 
We conducted structured interviews with officials from each of 
FDAs 19 district offices.  Our interview questions focused on how 
FDA oversees inspections conducted under contract with FDA.  
Specifically, we asked officials about how FDA tracks the 
completion of contract inspections, audits State inspectors and 
identifies deficiencies, and classifies contract inspections.  We 
conducted these interviews with the district offices between March 
and April 2010.  Additionally, we interviewed key FDA 
headquarters officials throughout the study.  We asked these 
officials questions similar to those we asked in interviews with 
district officials, as well as additional questions to help clarify how 
they oversee contract inspections.  
Limitations  
We relied on FDA data to determine the extent to which States 
completed the inspections required by their contracts.  We did not 
independently verify the accuracy of FDAs data.  
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. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  9     
 F I N D I N G S  
 
FDA has increasingly relied on States to   The overall number of 
inspect food facilities  facilities inspected has 
decreased from just over 
17,000 facilities in FY 2004 to about 15,900 in FY 2009.  Over this 
same period, the numberas well as the percentageof facilities 
inspected by States under contract with FDA has increased 
significantly.  In FY 2009, 59 percent of FDAs food inspections 
were conducted by State inspectors, compared to only 42 percent 
in FY 2004.  (See Table 1.)   
 
Table 1:  Food Facilities Inspected by FDA and by States Under Contract 
With FDA, FYs 20042009  
  Number of Food 
Number of Food  Facilities  Percentage of 
Total Number of  Facilities  Inspected by  Food Facilities 
Fiscal  Food Facilities  Inspected by FDA   States Under   Inspected by 
Year  Inspected  FDA Contract  States  
2004  17,032  10,354  7,073  42% 
2005  15,773  8,247  7,828  50% 
2006  14,547  7,065  7,695  53% 
2007  14,418  6,118  8,506  59% 
2008  15,055  6,209  9,050  60% 
2009  15,920  6,796  9,430  59% 
Note:  The number of facilities inspected by FDA and the number of facilities inspected by States are not mutually 
exclusive and therefore do not sum to the total number of facilities inspected.  On average, 271 facilities were 
inspected by both FDA and States in each FY.   
Source:  OIG analysis of FDA data, 2010. 
According to FDA officials, one reason FDA relies on States is that 
these inspections are conducted under State regulatory authority, 
which often exceeds FDAs own authority.  For example, several 
FDA officials noted that, under certain conditions, State inspectors 
can immediately shut down a facility or seize unsafe food products, 
whereas FDA would have to go through a lengthy legal process to 
achieve similar results.  
FDA officials also noted that the Food Safety Modernization Act 
gives FDA additional inspection responsibilities and provides a 
mandate from Congress to continue to work closely with States to 
conduct these additional inspections.  Officials reported that their 
goal is to establish an integrated, nationwide food-safety system 
with equivalent and coordinated inspections, inspection 
requirements, and training for inspectors.   
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  10     
F I N D I N G S  
In eight States, FDA failed to ensure that the required  Each year, FDA 
enters into contracts 
number of inspections was completed; FDA paid for 
with States.  These 
many inspections that were incomplete 
contracts specify the 
total number of inspections that each State must complete during 
the contract year.  FDA is responsible for ensuring that States 
conduct the required number of inspections and for appropriately 
paying the States for them.35  
According to FDA data, inspections in 8 of the 41 States were not 
completed.  As a part of completing inspections, each State must 
submit an inspection report that details the findings of the 
inspection.  Each of these inspection reports is then required to be 
included in FDAs inspections database.  For these eight States, 
the required reports were not contained in FDAs inspections 
database, nor could FDA locate paper copies of the reports.  As a 
result, FDAs data indicate that the required inspections were not 
completed in accordance with FDA guidance. 
 
 
Table 2:  Number of Required Inspections Not Completed, Based on FDA 
Data, 2009    
 
Number of Inspections  Number of Inspections  Number of Inspections 
State  in Contract  Completed  Not Completed 
 
Nevada  153  59  94 
California     335  248  87 
West Virginia  125  102  23 
 
Oklahoma  300  290  10 
 
Connecticut  70  67  3 
Texas    685  683  2 
Maine  32  31  1 
Virginia     470  469  1 
    Total    2,170  1,949  221 
Source:  OIG analysis of FDA data, 2010. 
 
As shown in Table 2, these 8 States were responsible for 
completing a total of 2,170 inspections; however, FDA had no 
 
 35 For detailed information about each States contract and the number of required 
inspections, see Appendix C.   
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  11     
F I N D I N G S  
 
documentation indicating that 10 percent (or 221) of these 
inspections were conducted during the contract year.   
FDA paid for most of these incomplete inspections without first 
verifying that the inspections had been completed and that the 
inspection reports were contained in FDAs database as required.  
Of the 221 inspections not completed, FDA paid for 130.  FDA 
officials explained that they do not typically verify that inspections 
are contained in FDAs database prior to making payments to 
States.  As a result, officials did not know whether the inspections 
they were paying for had been completed.  When FDA does not 
verify that inspections are completed prior to payment, States may 
be paid inappropriately. 
In four additional States, FDA paid for inspection visits, even though 
payment for such visits was not specified in the States contracts 
As noted earlier, an inspection visit occurs when an inspector 
visits a food facility but cannot complete the inspection.  Each 
contract should specify whether the State will be compensated for 
inspection visits.  However, a number of States had contracts that 
did not mention inspection visits or state whether these visits 
should be paid for by FDA.  Officials noted that they do not 
routinely verify whether payments for inspection visits are 
allowable under the contracts prior to making payments to States.  
Several FDA officials have noted that this is because FDA has 
traditionally paid for inspection visits regardless of what was 
included in the contracts. 
   
FDA is responsible for 
FDA did not ensure that all State inspections were 
classifying State inspections 
properly classified and that all violations  
and for working with States to 
were remedied  
remedy violations.  According 
to FDA guidance, uniform classification of State inspections is 
critical to the success of FDAs food safety program.36  It is also 
critical that FDA ensure that all inspection violations are 
remedied, so that it may be assured of the safety of food produced 
by facilities that had serious violations. 
 
36 FDA, Office of Regulatory Affairs, Field Management Directive No. 86:  
Establishment Inspection Report Conclusions and Decisions (rev. June 7, 2007).  
Accessed at http://www.fda.gov on January 28, 2011. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  12     
F I N D I N G S  
 
FDA did not ensure that all contract inspections were properly 
classified; as a result, FDA was unable to assess the relative risk of 
facilities 
In discussions with FDA officials, we learned that officials 
responsible for 11 of 41 States were unclear about how to properly 
classify contract inspections.  As noted earlier, FDA assigns each 
inspection an OAI, VAI, NAI, or RTS classification; OAI 
classifications generally are assigned when the most serious 
violations are identified.  In these 11 States, FDA officials reported 
that they would not assign OAI classifications to State inspections 
under any circumstances and instead assigned only VAI or RTS 
classifications for facilities with the most serious violations, 
contrary to FDA guidance.  Several of the officials responsible for 
these 11 States noted that they believed that OAI classifications 
could not be used for State contract inspections.   
In addition, despite that fact that FDA conducted fewer 
inspections than States, FDA inspections were much more likely to 
receive OAI classifications when compared to State contract 
inspections.  Among all inspections conducted between                
FYs 2004 and 2009, those conducted by FDA inspectors received 
almost five times as many OAI classifications as those conducted 
by State inspectors.  Although this disparity can be explained, in 
part, by the fact that FDA more frequently inspects high-risk 
facilities, this alone does not explain such a significant disparity 
between State and FDA inspections.37   
If FDA does not correctly classify inspections with serious 
violations, its ability to assess facilities relative risk is impaired.  
Beginning in FY 2011, FDA began assigning facilities numeric 
scores that were based partially on the number of past inspections 
that had been assigned OAI classifications.  If FDA does not 
properly classify State contract inspections with the most serious 
violations, it cannot easily determine the facilities that pose 
greater risks for foodborne illness.   
FDA did not know whether all inspection violations were remedied 
FDA officials reported that depending on the State and the nature 
of the violations, FDA, the State, or both assume responsibility for 
 
37 See Appendix D for a comparison of the number of OAI classifications assigned for 
inspections conducted by States versus those conducted by FDA. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  13     
F I N D I N G S  
 
addressing any violations identified during State inspections.  In 
all cases, FDA is responsible for ensuring that any State actions 
taken are adequate to ensure that the violations found during 
inspections are corrected.  FDA officials responsible for 11 States 
reported that when States were responsible for ensuring that 
violations were corrected, FDA was not always informed about 
States actions.  As a result, FDA was unable to ensure that 
serious violations had been adequately addressed.   
  
FDA oversees State 
FDA failed to complete the required number of 
inspections through its 
audits for one-third of the States and did not 
Contract Inspection Audit 
always follow up on systemic problems identified 
Program.  To perform an 
       audit, an auditor 
accompanies a State inspector who is conducting a contract 
  
inspection.  FDA guidance requires that a minimum of 7 percent of 
its contract inspections be audit ed each year.  This minimum
which is known as the minimum audit rateensures that the 
 
quality of the inspections conducted by States is adequate and that 
States are satisfying the requirements of their contracts.  In 
addition to conducting these audits, FDA is also responsible for 
following up on any systemic problems identified.   
FDA failed to complete the required number of audits in 14 of         
41 States  
For one-third of the States with contracts, FDA did not complete 
the required number of audits and therefore failed to meet its 
minimum audit rate.  Specifically, in these States, FDA failed to 
complete 38 percent (85 of 222) of the required audits.38  For each 
of these 14 States, FDA was responsible for conducting the 
required audits and for meeting the minimum audit rate.  For the 
2009 contract year, 553 required audits were completed for all 
States under contract.39  
FDA officials generally attributed their inability to complete the 
required number of audits to a lack of resources.  For example, one 
 
38 Note that four States met their minimum audit rate because FDA lowered the 
rate and audited a reduced number of inspections.     
39 See Appendix E for the total number of audits completed for each State during the 
2009 contract year. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  14     
F I N D I N G S  
official noted that his district ran out of the travel funds needed to 
complete the audits; another official noted a lack of trained FDA 
auditors available to conduct the audits.  Without conducting the 
minimum number of required audits, FDA cannot effectively 
ensure that State inspectors are following proper procedures and 
adequately identifying violations during inspections. 
When audits were conducted, they most commonly found problems 
with inspectors ability to identify violations 
Of the 419 inspectors audited in the 2009 contract year, 32 percent 
had at least 1 deficiency.  Of the inspectors with deficiencies, over 
half failed to properly identify violations in food facilities.  
Specifically, these inspectors had at least one of the following 
deficiencies: 
  failure to properly evaluate the likelihood that conditions, 
practices, components, and/or labeling could cause the product 
to be adulterated or misbranded;   
  failure to assess employee practices critical to the safe 
production and storage of food; and 
  failure to recognize violative conditions or practices (if present) 
and record findings consistent with State procedures.   
Examples of these deficiencies include instances in which the 
auditors noted that the inspectors did not write up evidence of 
rodents, did not notice a leaky roof above exposed food, or did not 
notice broken glass that could find its way into a food product.   
The audits in 10 States revealed systemic problems that needed to be 
corrected; FDA often failed to correct them  
According to FDA guidance, a systemic problem exists when audits 
identify the same deficiency in four or more audits during the 
same contract year or when 20 percent of the performance factors 
in a State are rated as needing improvement.   
The audits in 10 States revealed systemic problems that needed to 
be corrected.  Of the 10 States with systemic problems, 9 had 
audits that identified the same deficiency in 4 or more audits.  The 
most common systemic problem was the inspectors failure to 
identify violations.  For example, four of these States had systemic 
problems because four or more inspectors did not properly 
evaluate the likelihood that conditions, practices, components, 
and/or labeling could cause the product to be adulterated or 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  15     
FF II NN DD II NN GG SS   
 
misbranded.  The 10th State had more than 20 percent of its 
performance factors rated as needing improvement.    
FDA officials initiated corrective action in 4 of the 10 States with 
systemic problems.40  In another 5 of these 10 States, FDA did not 
analyze the audit data and was, therefore, unaware of the 
systemic problems in those States.  For the remaining State, FDA 
knew about the problem but did not take any corrective action.  If 
FDA does not follow its own guidance and address systemic 
problems found during its audits, it cannot verify that States are 
conducting suitable inspections that satisfy the requirements of 
the contracts, nor can it be assured of the safety of food facilities 
inspected by those States.  
In addition to revealing these systemic problems, several audits 
identified problems with the performance of individual inspectors 
whose overall ratings indicated that their performance needed 
improvement.  Specifically, 3 of the 419 inspectors received overall 
ratings of needing improvement, and 1 of those inspectors received 
an overall rating of needing improvement in 2 separate audits.  
State inspectors who receive overall ratings of needing 
improvement are supposed to receive remedial training from 
either FDA or the State prior to resuming inspection duties.  For 
two of these three inspectors, the State arranged remedial 
training; for the remaining inspector, FDA failed to take any 
corrective action.  
 
40 In one of these four States, FDA initiated corrective action as a result of our 
inquiry.   
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  16     
 R E C O M M E N D A T I O N S  
 
FDA has increasingly relied on States to conduct food facility 
inspections.  Further, the FDA Food Safety Modernization Act 
substantially increased the number of inspections that FDA needs 
to complete annually, and FDA has indicated that it will continue 
to rely on States to help conduct these additional inspections.  As a 
result, it is critical that the agency monitor and oversee these 
inspections. 
Our report identified significant weaknesses in FDAs oversight of 
State food facility inspections.  Notably, in eight States, FDA 
failed to ensure that the required number of inspections was 
completed and paid for many inspections that were incomplete.  If 
States fail to complete the number of inspections required in their 
contracts, FDAs ability to identify facilities with potentially 
serious food safety violations is diminished.   
Also, FDA did not ensure that all contract inspections were 
properly classified or that all inspection violations were remedied.  
Finally, FDA failed to complete the required number of audits for 
one-third of the States, and when audits were performed, FDA 
often failed to address the systemic problems identified.  If FDA 
does not conduct the required number of audits and fails to 
address systemic problems, it cannot verify that States are 
conducting suitable inspections that satisfy the requirements of 
the contracts, nor can it assure the safety of food facilities 
inspected by those States.  
Taken together, the findings demonstrate that more needs to be 
done to protect public health and to ensure that contract 
inspections are effective and prevent outbreaks of foodborne 
illness.  Therefore, we recommend that FDA:  
Ensure that all contract inspections are completed, properly 
documented, and appropriately paid for 
FDA should ensure that all inspections required by the contracts 
are completed and properly documented in its inspections 
database prior to making payments to States.  FDA should also 
verify that inspection visits are allowable under the contracts prior 
to making such payments.  At a minimum, FDA should annually 
review its data to ensure that all inspections are completed and 
documented in its database.  By putting these controls in place, 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  17     
R E C O M M E N D A T I O N S  
FDA would ensure that it pays appropriately for contract 
inspections.   
Ensure that contract inspections are properly classified in accordance 
with FDA guidance  
FDA should properly classify all contract inspections, especially 
those in which the most serious violations are found.  FDA may 
need to revise its guidance to clarify the circumstances under 
which OAIs should be given for contract inspections.  FDA may 
also need to conduct training for district office officials to ensure 
that the guidance is consistently applied.  Appropriate 
classification of inspections will improve FDAs ability to assess 
the relative risk of facilities. 
Ensure that all inspection violations are remedied by routinely 
tracking all actions taken to correct violations  
FDA should ensure that violations identified during contract 
inspections have been corrected.  If FDA determines that States 
are responsible for correcting food facility violations, it should 
require that the States notify FDA of all actions taken.  FDA may 
also consider expanding the capability of its inspections database 
or consider developing a tracking system to monitor the corrective 
actions taken by States as well as facilities responses.   
Ensure that the minimum audit rate is met in all States  
Audits ensure that States conduct suitable inspections that satisfy 
contract requirements.  FDA should ensure that 7 percent of State 
contract inspections are audited each year.  If FDA reduces a 
States minimum audit rate, it should ensure that the lowered rate 
is sufficient to determine whether the State is conducting suitable 
inspections.    
Address any systemic problems identified by audits 
FDA should analyze all audit deficiencies to determine when 
corrective action is necessary.  FDA should review deficiency data 
for the entire State to identify any systemic problems.  When 
problems are identified, FDA should ensure that corrective action 
is taken and that all problems have been addressed.  FDA should 
also review deficiency data on individual State inspectors and 
ensure that they receive the required remedial training, or other 
actions as necessary, and that deficiencies are addressed.  FDA 
should also work with States to ensure that inspectors receive 
additional training in areas where a significant number of them 
are deficient. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  18     
R E C O M M E N D A T I O N S  
AGENCY COMMENTS AND OFFICE OF INSPECTOR 
GENERAL RESPONSE 
In its response to the draft report, FDA concurred with four of our 
recommendations and agreed in part with the fifth.  It noted that 
collaboration with its State partners is critical to an integrated 
national food safety system.  FDA also noted that the current 
oversight program is in transition and that although FDA 
continues its longstanding program audits of State inspections, it 
is moving forward to fully implement its Manufactured Food 
Regulatory Program Standards.   
In response to our first recommendation, to ensure that all 
contract inspections are completed, properly documented, and 
appropriately paid for, FDA concurred, stating that it is 
conducting a systematic review of the State contracting program.  
FDA further stated that it will ensure that processes are 
established to periodically review contract data.  In addition, FDA 
noted that it has instituted practices to ensure that it reviews all 
contracts before they are issued to confirm that the contractors 
have elected to either include or exclude inspection visits.  
In response to our second recommendation, to ensure that contract 
inspections are properly classified, FDA concurred and noted that 
it is revising its directive to emphasize more clearly that 
classifications must be accurate, timely, and uniform.  FDA stated 
that it will issue the revisions, post them on its Web site, and 
establish an outreach schedule to explain the revisions to all key 
stakeholders within its district offices.  
In response to our third recommendation, to ensure that all 
inspection violations are remedied by routinely tracking all actions 
taken to correct violations, FDA agreed to track most violative 
inspections and the remedies taken by industry.  However, FDA 
noted that certain violations may not be suitable for inspection 
followup and that other approaches may be used to track such 
violations.  FDA noted that it is evaluating and modifying its 
existing procedures to incorporate requirements for tracking State 
followup and actions to correct violations.  While we appreciate 
FDAs commitment to track certain violations, we encourage it to 
track all violations, even those that do not warrant followup 
inspections.  FDA can use violation information to help establish 
the relative risk of facilities and determine how often they should 
be inspected. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  19     
R E C O M M E N D A T I O N S  
In response to our fourth recommendation, to ensure that the 
minimum audit rate is met in all States, FDA concurred, noting 
that it is reviewing the current reporting requirements to ensure 
that audits are completed and tracked to verify compliance with 
FDA requirements.   
Finally, in response to our fifth recommendation, to address any 
systemic problems identified by audits, FDA concurred and noted 
that it will continue to develop processes and procedures to ensure 
that systemic problems are identified and that corrective action 
plans are implemented. 
We support FDAs efforts to strengthen State contract inspections 
and address the issues identified in this report.  With the 
implementation of the Manufactured Food Regulatory Program 
Standards, FDAs oversight of State inspections is even more 
critical.  As States adopt the standards, it is essential that FDA 
strengthen not only States oversight but also its own oversight to 
ensure that States conduct high-quality food facility inspections. 
For the full text of FDAs comments, see Appendix F.  We made 
minor changes to the report based on technical comments.
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  20     
 A P P E N D I X   A  
 
Table A-1:  Performance Factors of the Contract Audit 
Audit element* 
1.  Did the inspector review the States establishment file for the previous inspection report and possible complaints or access other 
available resources in preparation for the inspection? 
2.  Did the inspector have the appropriate equipment and forms to properly conduct the inspection? 
3.  Was FDA jurisdiction established? 
4.  Did the inspector select an appropriate product for the inspection and, if necessary, make appropriate adjustments based on what 
the firm was producing? 
5.  Did the inspector assess the employee practices critical to the safe production and storage of food? 
6.  Did the inspector properly evaluate the likelihood that conditions, practices, components, and/or labeling could cause the product to 
be adulterated or misbranded? 
7.  Did the inspector recognize significant violative conditions or practices (if present) and record findings consistent with State 
procedures? 
8.  Did the inspector demonstrate the ability to distinguish between significant verses insignificant observations and isolated incidents 
versus trends? 
9.  Did the inspector review and evaluate the appropriate records and procedures for this establishments operations and effectively 
apply the information obtained from this review? 
10.  Did the inspector collect adequate evidence and documentation in accordance with State procedures given the nature of the 
inspection findings? 
11.  Did the inspector verify correction of deficiencies identified during the previous State inspection? 
12.  Did the inspector act in a professional manner and demonstrate proper sanitary practices during the inspection? 
13.  Did the inspector identify himself/herself and make appropriate introductions, which include explaining the purpose and scope of 
the inspection? 
14.  Did the inspector use suitable interviewing techniques? 
15.  Did the inspector explain the findings clearly and adequately throughout the inspection? 
16.  Did the inspector alert the firms appropriate management when an immediate corrective action was necessary? 
17.  Did the inspector answer questions and provide information in an appropriate manner? 
18.  Did the inspector write his/her findings accurately, clearly, and concisely on the State form/document left with the firm? 
Performance factors specific to inspections of certain high-risk facilities 
1.  Did the inspector use the Fish and Fishery Products Hazards and Controls Guide or the Juice HACCP Hazards and Controls 
Guide, as appropriate, to identify and evaluate the hazards associated with the product and the process?** 
2.  Did the inspector assess the firms implementation of sanitation monitoring for the applicable eight key areas of sanitation? 
3.  Did the inspector review the firms HACCP plan (or necessary process controls in the absence of a HACCP plan) and applicable 
monitoring, verification, and corrective action records, including those related to sanitation? 
4.  Did the inspector recognize deficiencies in the firms monitoring and sanitation procedures through in-plant observations? 
*Taken from the Food and Drug Administration (FDA) Contract Audit Form 3610. 
 
**HACCP refers to Hazard Analysis and Critical Control Points, a food safety management system for foods or processes considered high risk by FDA. 
 
Source:  Office of Inspector General review of the FDA Contract Audit Form 3610, 2010. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  21     
 A P P E N D I X   B  
 
States Role in Conducting Audits as Part of the Food and Drug Administrations Contract 
Inspection Audit Program 
The Food and Drug Administrations (FDA) audit program allows States to assume 
responsibility for conducting their own audits of State inspectors.  If FDA and a State 
agree, the States assume responsibility for some or all of the audits.  The terms of these 
additional responsibilitiesas well as the amount of additional compensation received by 
the Statesare specified in the States contracts.  The audit program is made up of three 
successive phases of increasing responsibility assumed by the States:  
Phase 1.  In the first phase, trained FDA auditors conduct all of the audits of State 
inspectors.  In this phase, FDA must meet the 7-percent minimum audit rate.41 
Phase 2.  In the second phase, both FDA and State auditors conduct the audits of State 
inspectors.  Before he or she is allowed to conduct audits independently, a State auditor 
trainee must have the appropriate qualifications.  The trainee must then observe an FDA 
auditor performing an audit of a State inspector.  Finally, an FDA auditor must verify that 
the trainees performance is acceptable by observing an audit.  Once State auditors are 
deemed qualified, the State can work with FDA to meet the 7-percent minimum audit rate; 
however, FDA is ultimately responsible for ensuring that the minimum audit rate is met.   
Phase 3.  In the third phase, State auditors conduct all audits of State inspectors, and 
State auditors are solely responsible for meeting the 7-percent minimum audit rate.   
In this phase, FDA oversees State audits by auditing the performance of the State 
auditors.  These FDA verification audits are conducted during a State audit of a State 
inspection.  To perform these audits, FDA selects a representative sample of State audits.  
An FDA auditor then observes and assesses the State auditor and produces a 
memorandum with the results of the audit. 
See Table B-1 for the phase of the contract audit program for each State in the              
2009 contract year.   
 
 
41 FDA, Office of Regulatory Affairs, Field Management Directive No. 76:    III.B.  Accessed at http://www.fda.gov 
on January 28, 2011.  Although each contract is for 1 year, timeframes for auditing inspectors are based on the 
length of time since an inspector was last audited. 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  22     
A P P E N D I X   ~   B  
 
 
Table B-1:  Phases of the Contract Audit Program for the      
2009 Contract Year 
 
States in Phase 1  States in Phase 2  States in Phase 3   
Alabama, California,  Colorado, North Carolina,  Arkansas, Alaska, Maryland, 
Connecticut, Florida, Georgia,   South Carolina,* Tennessee  Michigan, Mississippi, Missouri, 
Illinois, Iowa, Kansas,  New York, Oregon, West 
Kentucky, Louisiana, Maine,    Virginia,*  Wisconsin, 
Massachusetts, Minnesota, 
Montana, Nebraska, Nevada, 
New Jersey, Ohio, Oklahoma,  
Pennsylvania, Puerto Rico, 
Rhode Island, South 
Carolina,* Texas, Virginia,  
Vermont, Washington, West 
Virginia,* Wyoming 
*FDA had two contracts with two different State agencies in West Virginia and South Carolina; in both States, these 
two agencies were in different phases of the audit program.   
 
Source:  Office of Inspector General analysis of FDA State contracts, 2010. 
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  23     
 A P P E N D I X   C  
 
Table C-1:  Description of Services in State Contracts for the 2009 Contract Year 
Implementing 
Inspection  Manufactured 
Total Food  Visits  Food Regulatory 
Inspections  Included in  Program  Other Services Listed in the 
State  Required  Contract  Standards  Contract 
Alabama  175  Yes  Yes  Training and travel   
Alaska  292  Yes  Yes  Training and travel 
Arkansas  200  Yes  No  None 
California  335  No  No  Training and travel 
Colorado  207  Yes  Yes  Training, travel, and samples 
Connecticut  70  Yes  No  Training and travel 
Florida  490  No  No*  Training, travel, and samples 
Georgia  225  Yes  Yes  Training and travel 
Illinois  390  Yes  No  None 
Iowa  150  No  No  None 
Kansas  125  Yes  Yes  Training and travel 
Kentucky  136  Yes  No  Training and travel 
Louisiana  200  No  No  Training and travel 
Maine  32  Yes  No  None 
Maryland  180  No  Yes  Training, travel, and samples 
Massachusetts  275  Yes  Yes  Training and travel 
Michigan  410  No  Yes  Training, travel, and samples 
Minnesota  282  Yes  No*  Training and travel 
Mississippi  100  No  Yes  Training and travel 
Missouri  450  Yes  Yes  Training and travel 
Montana  90  No  No  Training and travel 
Nebraska  130  Yes  No  Training and travel 
Nevada  153  Yes  No  Training and travel 
New Jersey  411  Yes  No  Training and travel 
New York  378  Yes  Yes  Training and travel 
North Carolina  254  Yes  Yes  Training and travel 
Ohio  500  Yes  No  Training, travel, and samples 
Oklahoma  300  Yes  Yes  Training and travel 
Oregon  750  No  Yes  Training and travel 
Pennsylvania  100  No  No  None 
Puerto Rico  90  No  No  None 
Rhode Island  150  Yes  Yes  Training and travel 
South Carolina Department of Agriculture  115  Yes  Training and travel 
South Carolina Department of Health  33  Yes  Yes  Training, travel, and samples 
Tennessee  185  No  No  Training and travel 
Texas  685  Yes  No  Training and travel 
Vermont  8  No  Yes  Training and travel 
Virginia  470  Yes  No*  Training and travel 
Washington  550  Yes  Yes  Training and travel 
West Virginia Department of Agriculture  45  Yes  No  None 
West Virginia Department of Health  80  Yes  Yes  Training and travel 
Wisconsin  289  Yes  Yes  Training and travel 
Wyoming  35  No  Yes  Training and travel 
    Total      10,525   
*State has agreed to implement the Manufactured Food Regulatory Program Standards, but not as part of its contract with the Food and Drug 
Administration (FDA). 
 
Source:  Office of Inspector General analysis of FDAs State contracts and documentation, 2010. 
 
 
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  24     
 A P P E N D I X   D  
Table D-1:  Number of Inspections Classified as Official Action Indicated Conducted by 
FDA* and by States, FYs 20042009 
Number of FDA Inspections Classified as  Number of State Inspections Classified as 
Fiscal Year  Official Action Indicated   Official Action Indicated 
2004  540  118 
2005  425  113 
2006  323  124 
2007  244  32 
2008  266  12 
2009  371  47 
Average from 2004 to 2009  362  74 
 *Food and Drug Administration.           
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
Source:  Office of Inspector General analysis of FDA data, 2010. 
 
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  25     
 A P P E N D I X   E  
Table E-1:  Audits Completed for the 2009 Contract Year, by State 
Minimum   Number of  Additional   Met the 
Number of  Required Audits  Audits  Minimum 
State  Audits Required  Completed  Completed  Audit Rate? 
Alabama  12  5  0  No 
Alaska  20  20  0  Yes 
Arkansas  4*  4  10  Yes 
California  23  18  0  No 
Colorado  14  14  0  Yes 
Connecticut  4  4  0  Yes 
Florida  34  34  0  Yes 
Georgia  15  15  4  Yes 
Illinois  27  18  0  No 
Iowa  10  3  0  No 
Kansas  8  4  0  No 
Kentucky  9  9  1  Yes 
Louisiana  14  14  0  Yes 
Maine  2  2  0  Yes 
Maryland  12  12  2  Yes 
Massachusetts  10*  10  2  Yes 
Michigan  28  28  1  Yes 
Minnesota  7*  7  16  Yes 
Mississippi  7  7  2  Yes 
Missouri  6*  6  0  Yes 
Montana  1*  1  2  Yes 
Nebraska  9  3  0  No 
Nevada  10  0  0  No 
New Jersey  20*  20  0  Yes 
New York  26  26  1  Yes 
North Carolina  17  17  1  Yes 
Ohio  35  35  0  Yes 
Oklahoma  21  4  0  No 
Oregon  52  52  0  Yes 
Pennsylvania  7  6  0  No 
Puerto Rico  6  6  0  Yes 
Rhode Island  10  6  0  No 
South Carolina Department of Agriculture  8   6  0  No 
South Carolina Department of Health  2  2  2  Yes 
Tennessee  12  12  1  Yes 
Texas  35*  34  0  No 
Vermont  1  1  0  Yes 
Virginia  32  23  0  No 
Washington  38  38  3  Yes 
West Virginia Department of Agriculture  3  0  0  No 
West Virginia Department of Health  5  5  1  Yes 
Wisconsin  20  20  0  Yes 
Wyoming  2  2  0  Yes 
Total  638  553  49   
One of the two agencies in South Carolina and in West Virginia failed to meet the audit rate; in these instances, we counted the State as having failed 
to meet the audit rate.    
 
*The Food and Drug Administration (FDA) lowered the minimum audit rate for this State. 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
Source:  Office of Inspector General analysis of FDAs audit forms and documentation, 2010. 
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  26  x 
A  P  PEN  D  F 
Agency Comments 
......
(4~.D..  ... .. ...  ..  . 
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..ALTI!..... .. ___
.Food ~nd Drug Admlnls.trafton 
Sliver 6prJngMD 20Q93 . 
DATE:  October 28,2011 
TO:  Deputy Inspector General for EVllluations and Inspections, orG 
FROJ\il:  Acting Associate Commissioner for PoJicy and Planning, FDA 
SUB,JECT:FDA's Re~ponse to oro's draft report entitled, Vulnerabilities in Fl)A's 
Oversight ofState Food Facility Jnspections.OEI~02c09-00430 
FDA is providing the ilttachcd response to the Office ofInspector General's draft report 
.. entitled, Vulnerabilities in FDA's Oversight bjState. Foodfacility Inspections,  . 
OEI~02-09-00430. 
FDA appreciates the opportunity to comment on this draft report. 
David Dorsey,J .D. 
Attachment 
OEI020900430  VULNERABILITIES IN FDA's OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  27     
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OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  28     
A P P E N D I X   ~   F  
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  29     
A P P E N D I X   ~   F  
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  30     
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OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  31     
AAAA PPPP APPPP EEEEC NNNNK DDDDN IIIIOXXXX W     ~~~~L     E FFFFD     G M E N T S  
 
 
This report was prepared under the direction of Jodi Nudelman, 
Regional Inspector General for Evaluation and Inspections in the 
New York regional office, and Meridith Seife, Deputy Regional 
Inspector General.   
Vincent Greiber served as the team leader for this study.  Other 
principal Office of Evaluation and Inspections staff from the New 
York regional office who contributed to the report include Levita 
Lowe, and Bailey G. Orshan; central office staff who contributed 
include Kevin Farber and Sandy Khoury.  
 
 
OEI-02-09-00430    VULNERABILITIES IN FDAS OVERSIGHT OF STATE FOOD FACILITY INSPECTIONS  32     
Office  of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 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 beneficiaries 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: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.