Department of Health and Human Services 

OFFICE OF

INSPECTOR GENERAL

 

VULNERABILITIES IN FDA’S 

OVERSIGHT OF STATE FOOD 

FACILITY INSPECTIONS 

 

Daniel R. Levinson 

Inspector General 

December 2011 

OEI-02-09-00430 
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INTRODUCTION EXECUTIVE SUMMARY

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 Nation’s 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 FDA’s 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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EXECUTIVE SUMMARY

inspections that satisfy the requirements of their contracts. FDA 

requires that a minimum of 7 percent of a State’s contract inspections 

be audited each year. This minimum percentage—which is known as 

the minimum audit rate—ensures that States are conducting adequate 

inspections that meet the conditions of the contract. 

We based this study on several sources of data: (1) FDA’s inspection 

data, (2) FDA’s 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 FDA’s 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, FDA’s 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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EXECUTIVE SUMMARY

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 FDA’s 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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EXECUTIVE SUMMARY

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 

FDA’s 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 FDA’s efforts to strengthen State contract inspections and 

address the issues identified in the report. With the implementation of 

the Manufactured Food Regulatory Program Standards, FDA’s 

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.
 

 TABLE OF CONTENTS

EXEC UTIVE SUMMARY ................................ ..... i

INTRODUCTION ............................................ 1 

FINDINGS ................................................. 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

RECOMMENDATIONS ..................................... 17

Agency Comments and Office of Inspector General Response.... 19

APPENDIXES ............................................. 21 

A: Performance Factors of the Contract Audit ............... 21

B: States’ Role in Conducting Audits as Part of the 

Food and Drug Administration’s 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 2004–2009 ......... 25 

E: Audits Completed for the 2009 Contract Year, by State ..... 26

F: Agency Comments ................................... 27

ACKNOWLEDGMENTS ..................................... 32
 

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 INTRODUCTION

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 Nation’s 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

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.

 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. 

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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INTRODUCTION

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 FDA’s oversight of the program. 

Among other things, the Committee was concerned about State 

inspections conducted under contract with FDA, as well as FDA’s 

audits of these inspections. 

FDA’s 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 FDA’s inspections.

 

5

Officials from FDA’s 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 

FDA’s behalf.

 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. 

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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INTRODUCTION

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)(6–8).

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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INTRODUCTION

Federal jurisdiction over the violation in question or that State 

action is the most efficient method of obtaining compliance.14

FDA’s 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 State’s contract inspections be audited 

each year. This minimum percentage—which is known as the 

minimum audit rate—ensures 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 inspector’s 

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

14 FDA, Office of Regulatory Affairs, Field Management Directive No. 86: 

Establishment Inspection Report Conclusions and Decisions (rev. June 7, 2007). 

Accessed at 

 FDA uses the 

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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INTRODUCTION

threshold of four or more audits to determine whether a specific 

aspect of a State’s 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 State’s 

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

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 State’s 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

 See Appendix B for more detailed information about the 

States’ role in conducting audits.

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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INTRODUCTION

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 

FDA’s 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

OIG has also completed a number of other studies evaluating 

FDA’s role in ensuring food safety. In a 2010 report evaluating 

FDA’s 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.

In response to the report, FDA developed its Contract 

Inspection Audit Program. 

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 FDA’s 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, FDA’s Food Facility Registry, OEI-02-08-00060, December 2009.
 

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INTRODUCTION

METHODOLOGY

Scope 

This study assesses FDA’s 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 FDA’s 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 FDA’s 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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INTRODUCTION

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 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 

 We took into account any instances in 

which FDA had requested a lowered audit rate for a State. 

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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INTRODUCTION

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 

FDA’s 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 FDA’s 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.
 

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 FINDINGS

FDA has increasingly relied on States to 

inspect food facilities

The overall number of 

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 number—as well as the percentage—of facilities 

inspected by States under contract with FDA has increased 

significantly. In FY 2009, 59 percent of FDA’s 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 2004–2009 

Fiscal 

Year

Total Number of 

Food Facilities 

Inspected

Number of Food 

Facilities 

Inspected by FDA 

Number of Food 

Facilities 

Inspected by 

States Under 

FDA Contract

Percentage of 

Food Facilities 

Inspected by 

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 FDA’s 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. 
 

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F I NDINGS

In eight States, FDA failed to ensure that the required 

number of inspections was completed; FDA paid for 

many inspections that were incomplete

Each year, FDA 

enters into contracts 

with States. These 

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 FDA’s inspections database. For these eight States, 

the required reports were not contained in FDA’s inspections 

database, nor could FDA locate paper copies of the reports. As a 

result, FDA’s 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 

State

Number of Inspections 

in Contract

Number of Inspections 

Completed

Number of Inspections 

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 State’s contract and the number of required 

inspections, see Appendix C. 
 

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FINDINGS

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 FDA’s 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 FDA’s 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.

 

http://www.fda.gov on January 28, 2011.

FDA did not ensure that all State inspections were 

properly classified and that all violations 

were remedied 

FDA is responsible for 

classifying State inspections 

and for working with States to 

remedy violations. According 

to FDA guidance, uniform classification of State inspections is 

critical to the success of FDA’s 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 
 

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FINDINGS

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.
 

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FINDINGS

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 failed to complete the required number of 

audits for one-third of the States and did not 

always follow up on systemic problems identified 

 

FDA oversees State 

inspections through its 

Contract Inspection Audit 

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 audited each year. This minimum—

which is known as the minimum audit rate—ensures 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.
 

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FINDINGS

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 
 

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FINDINGS

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 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. 

 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. 

40 In one of these four States, FDA initiated corrective action as a result of our 

inquiry. 
 

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 RECOMMENDATIONS

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 FDA’s 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, FDA’s 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, 
 

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RECOMMENDATIONS

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 FDA’s 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 

State’s 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.
 

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RECOMMENDATIONS

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 

FDA’s 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.
 

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RECOMMENDATIONS

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 FDA’s efforts to strengthen State contract inspections 

and address the issues identified in this report. With the 

implementation of the Manufactured Food Regulatory Program 

Standards, FDA’s 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 FDA’s comments, see Appendix F. We made 

minor changes to the report based on technical comments.
 

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 APPENDIX A

Table A-1: Performance Factors of the Contract Audit

Audit element* 

1. Did the inspector review the State’s 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 establishment’s 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 firm’s 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 firm’s implementation of sanitation monitoring for the applicable eight key areas of sanitation?

3. Did the inspector review the firm’s 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 firm’s 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.
 

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 APPENDIX B

States’ Role in Conducting Audits as Part of the Food and Drug Administration’s Contract 

Inspection Audit Program

The Food and Drug Administration’s (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 responsibilities—as well as the amount of additional compensation received by 

the States—are 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 trainee’s 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 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.

. 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. 

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.
 

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APPENDIX ~ 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, 

Connecticut, Florida, Georgia, 

Illinois, Iowa, Kansas, 

Kentucky, Louisiana, Maine, 

Massachusetts, Minnesota,

Montana, Nebraska, Nevada, 

New Jersey, Ohio, Oklahoma, 

Pennsylvania, Puerto Rico,

Rhode Island, South 

Carolina,* Texas, Virginia, 

Vermont, Washington, West 

Virginia,* Wyoming

Colorado, North Carolina, 

South Carolina,* Tennessee

Arkansas, Alaska, Maryland, 

Michigan, Mississippi, Missouri, 

New York, Oregon, West 

Virginia,* Wisconsin,

*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.
 

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 APPENDIX C

Table C-1: Description of Services in State Contracts for the 2009 Contract Year

State

Total Food 

Inspections 

Required

Inspection 

Visits 

Included in 

Contract

Implementing 

Manufactured 

Food Regulatory 

Program 

Standards

Other Services Listed in the 

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

Yes

Training and travel

South Carolina Department of Health 33 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 FDA’s State contracts and documentation, 2010.
 

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 APPENDIX D

Table D-1: Number of Inspections Classified as Official Action Indicated Conducted by 

FDA* and by States, FYs 2004–2009

Fiscal Year

Number of FDA Inspections Classified as

Official Action Indicated 

Number of State Inspections Classified as 

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.
 

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 APPENDIX E

Table E-1: Audits Completed for the 2009 Contract Year, by State

State

Minimum 

Number of 

Audits Required

Number of 

Required Audits 

Completed

Additional 

Audits 

Completed

Met the 

Minimum 

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 FDA’s audit forms and documentation, 2010.
A P PEN D x F 

Agency Comments 

......~... . ... .. . 

(4D....~P'..ALTI!.....V~._.~,-..•·_SE_R_V_IC_E_S_~_-'-___-,-~~.,..,--'-~ .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 

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APPENDIX ~ F ACKNOWLEDGMENTS

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. 
 

 

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. 

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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 OIG’s 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 

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guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.