Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

 

FDA INSPECTIONS OF DOMESTIC 

FOOD FACILITIES 

 

 

Daniel R. Levinson 

Inspector General 

April 2010 

OEI-02-08-00080 
 

 EXECUTIVE SUMMARY 

OBJECTIVES 

To determine the extent to which the Food and Drug Administration 

(FDA): 

1. conducts inspections of domestic food facilities, 

2. identifies violations in food facilities and takes action against those 

food facilities, and 

3. ensures that violations are corrected. 

BACKGROUND 

Each year, more than 300,000 Americans are hospitalized and 5,000 die 

after consuming contaminated foods and beverages. Recent high-profile 

outbreaks of foodborne illness have raised serious questions about 

FDA’s inspections process and its ability to protect the Nation’s food 

supply. The Senate Committee on Agriculture, Nutrition, and Forestry 

requested that the Office of Inspector General (OIG) review the extent 

to which FDA conducts food facility inspections and identifies violations. 

FDA inspects food facilities to ensure food safety and compliance with 

regulations. During an inspection, FDA inspectors may identify 

potential violations of the Food, Drug, and Cosmetic Act as well as other 

applicable laws and regulations. Based on the outcome of the 

inspection, FDA assigns a facility one of three classifications: official 

action indicated (OAI), voluntary action indicated (VAI), or no action 

indicated (NAI). In addition, FDA may choose to change a facility’s 

initial classification to another classification under certain 

circumstances. 

According to FDA guidance, when inspectors uncover violations that are 

significant enough to warrant OAI classification, some type of 

regulatory action should be recommended. This regulatory action 

generally consists of either an advisory action or an enforcement action. 

Advisory actions usually allow an opportunity for the facility to 

voluntarily correct the violations found during the inspection, whereas 

enforcement actions are often initiated in court and the facility is 

generally required to correct the violations found during the inspection. 

FDA relies on several approaches to determine whether a facility 

corrected the violations found by inspectors. FDA may review evidence 

provided by a food facility describing any completed corrective actions. 

FDA may also reinspect a facility to verify that corrections were made. 

 OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES i 
 

EXECUTIVE SUMMARY 

We based this study on three data sources: (1) FDA’s food facility 

inspection data, (2) FDA documentation on facility violations and 

followup activities, and (3) structured interviews with FDA staff. 

FINDINGS 

On average, FDA inspects less than a quarter of food facilities each 

year, and the number of facilities inspected has declined over time. 

Between fiscal years (FY) 2004 and 2008, FDA inspected annually an 

average of 24 percent of the food facilities subject to its inspection. 

Except for a few instances, there are no specific guidelines that govern 

the frequency with which inspections should occur. Further, the 

number of food facilities that FDA inspected declined between 

FYs 2004 and 2008, even as the number of food facilities increased. In 

addition, the number of inspections of facilities that have been 

designated by FDA as “high risk” has also declined. FDA officials noted 

that the overall decline in FDA inspections was largely due to a decline 

in staffing levels. 

Fifty-six percent of food facilities have gone 5 or more years without 

an FDA inspection. FDA identified 51,229 food facilities that were 

subject to inspection and were in business from the start of 

FY 2004 until the end of FY 2008. Of these, 56 percent were not 

inspected at all, 14 percent were inspected a single time, and the 

remaining 30 percent were inspected two or more times. If FDA does 

not routinely inspect food facilities, it is unable to guarantee that these 

facilities are complying with applicable laws and regulations. 

The number of facilities that received OAI classifications has 

declined over time. The number of inspected facilities that received 

OAI classifications decreased from 614 in FY 2004 to 283 in 

FY 2008. The percentage of facilities that received OAI classifications 

also dropped from nearly 4 percent to nearly 2 percent during this 

5-year period. In addition, nearly three-quarters of the facilities that 

received OAI classifications in FY 2008 had a history of violations. 

Two percent of facilities that received OAI classifications refused to 

grant FDA officials access to their records. 

FDA took regulatory action against 46 percent of the facilities with 

initial OAI classifications; for the remainder, FDA either lowered the 

classification or took no regulatory action. In FY 2007, a total of 

446 facilities initially received OAI classifications. FDA took regulatory 

action against 46 percent of these facilities. For the remainder, FDA 

 OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES ii
 

EXECUTIVE SUMMARY 

lowered the OAI classification for 29 percent and took no regulatory 

action for 25 percent. 

For 36 percent of the facilities with OAI classifications in FY 2007, 

FDA took no additional steps to ensure that the violations were 

corrected. In FY 2007, 280 facilities received OAI classifications that 

were not lowered by FDA. For 36 percent of these facilities, FDA did 

not reinspect them within a year of the inspection or review other 

evidence provided by facilities to ensure that the violations were 

corrected. 

RECOMMENDATIONS 

Our report found significant weaknesses in FDA’s domestic inspections 

program. We found that there was a significant decline in the number 

of food facility inspections as well as a decline in the number of 

violations identified by FDA inspectors. Further, when violations were 

identified, FDA did not routinely take swift and effective action to 

ensure that these violations were remedied. Taken together, the 

findings demonstrate that more needs to be done to protect public 

health and to ensure that FDA has the necessary tools to prevent 

outbreaks of foodborne illness. Based on our findings, we recommend 

that FDA: 

Increase the frequency of food facility inspections, with particular 

emphasis on high-risk facilities. 

Provide additional guidance about when it is appropriate to lower OAI 

classifications. 

Take appropriate actions against facilities with OAI classifications, 

particularly those that have histories of violations. 

Ensure that violations are corrected for all facilities that receive OAI 

classifications. 

Consider seeking statutory authority to impose civil penalties through 

administrative proceedings against facilities that do not voluntarily 

comply with statutory and regulatory requirements. 

Seek statutory authority to allow FDA access to facilities’ records during 

the inspection process. 

 OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES iii
 

OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES iv 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

In its response to the draft report, FDA noted that it was addressing 

many of the issues and recommendations noted in the report. 

Specifically, FDA stated that it supported our two recommendations to 

seek additional statutory authority from Congress. It noted that it is 

seeking more effective enforcement tools and that it supports proposed 

legislation to expand civil penalties for food violations and to provide 

additional access to facilities’ records. FDA also agreed with our 

recommendation to provide additional guidance about when it is 

appropriate to lower OAI classifications and noted that it will revise its 

current guidance. 

For the remaining three recommendations, FDA noted several actions it 

has taken, or plans to take, to address them. FDA stated that it 

received increased appropriations that have permitted it to increase the 

number of food facility inspections. It also stated that it has taken steps 

to implement our recommendations to ensure that appropriate actions 

are taken and that violations are corrected for all facilities that receive 

OAI classifications. 

We support FDA’s efforts and continue to emphasize the importance of 

FDA taking appropriate and swift action and ensuring that violations 

are corrected in all facilities with OAI classifications. We ask that, in 

its final management decision, FDA more clearly indicate whether it 

concurs with each of the recommendations listed in the report. 

EXECUTIVE SUMMARY 
 
 

 OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES 0

EXECUTIVE SUMMARY .....................................i

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

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 

On average, FDA inspects less than a quarter of food 

facilities each year, and the number of facilities inspected 

has declined over time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 

Fifty-six percent of food facilities have gone 5 or more years 

without an FDA inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 

The number of facilities that received OAI classifications 

has declined over time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 

FDA took regulatory action against 46 percent of the facilities 

with initial OAI classifications; for the remainder, FDA either 

lowered the classification or took no regulatory action . . . . . . . . . 15 

For 36 percent of the facilities with OAI classifications 

in FY 2007, FDA took no additional steps to ensure that 

the violations were corrected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 

Agency Comments and Office of Inspector General Response . . . 22 

APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 

A: Facilities Inspected by Industry, Fiscal Years 2004 

and 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 

B: Percentage of Inspected Food Facilities by Classification, 

Fiscal Years 2004 and 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 

C: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

 TABLE OF CONTENTS 
 

 INTRODUCTION 

OBJECTIVES 

To determine the extent to which the Food and Drug Administration 

(FDA): 

1. conducts inspections of domestic food facilities, 

2. identifies violations in food facilities and takes action against those 

food facilities, and 

3. ensures that violations are corrected. 

BACKGROUND 

Each year, more than 300,000 Americans are hospitalized and 5,000 die 

after consuming contaminated foods and beverages.1 FDA is 

responsible for safeguarding the Nation’s food supply by ensuring that 

all ingredients used in food are safe and that food is free of 

disease-causing organisms, chemicals, or other harmful substances. 

The recent salmonella outbreak caused by insanitary conditions at a 

peanut processing plant resulted in one of the largest food recalls in 

U.S. history.2 This outbreak, as well as others resulting in large recalls 

of spinach, tomatoes, peppers, lettuce, and alfalfa sprouts, has raised 

serious questions about FDA’s inspections process and its ability to 

protect the Nation’s food supply. 

The Senate Committee on Agriculture, Nutrition, and Forestry requested 

that the Office of Inspector General (OIG) review the extent to which FDA 

conducts food facility inspections and identifies violations. Among other 

things, the Committee was concerned about reports that the number of 

food facility inspections is declining, even as the number of food facilities 

regulated by FDA is increasing. 

1 Paul S. Mead et al., “Food-Related Illness and Death in the United States,” Emerging 

Infectious Diseases, vol. 5, 1999, pp. 607–625. Available online at 

http://www.cdc.gov/ncidod/eid/Vol5no5/mead.htm. Accessed on December 14, 2009. 

2 FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint Media 

Teleconference, January 28, 2009. Available online at 

http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM169176.pdf. 

Accessed on August 11, 2009. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 1
 

INTRODUCTION 

Food Facility Inspections 

FDA inspects food facilities to ensure food safety and compliance with 

regulations. Pursuant to the Federal Food, Drug, and Cosmetic Act, 

FDA is responsible for ensuring the safety of almost all food products 

sold in the United States, with the exception of meat, poultry, and some 

egg products, which are regulated by the U.S. Department of 

Agriculture. 

FDA inspects food facilities that manufacture, process, pack, and store 

food.3 Inspectors from FDA’s 19 district offices conduct these 

inspections according to guidance from FDA headquarters. In addition, 

FDA contracts with States to conduct inspections on behalf of FDA.4 

Except for a few instances, there are no specific guidelines that govern 

the frequency with which inspections should occur.5 Instead, FDA’s 

district offices work with FDA headquarters to develop certain annual 

priorities for inspection. Throughout the course of the year, however, 

FDA may change its priorities based on emerging issues, such as 

outbreaks of foodborne illness. 

FDA also designates certain facilities as high-risk facilities. Generally, 

these facilities handle types of food that have a greater potential to 

cause harm. FDA uses this high-risk designation to help prioritize 

facilities for inspection. This process allows FDA to target scarce 

resources based on relative vulnerability and risk. 

In recent years, FDA has experienced significant decreases in staffing 

for its food program. Notably, in fiscal year (FY) 2003, FDA had 

3,167 full-time equivalent employees (FTE) responsible for the oversight 

of food facilities; by FY 2005, the number of employees had dropped to 

2,943; and by FY 2007, the number was down to 2,569.6 To address 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 2

3 21 U.S.C. § 374; 21 U.S.C. § 372. 

4 FDA also has partnership agreements with some States. These agreements allow States 

to share information with FDA about inspections they conduct. 

5 FDA has specific guidelines for inspections of manufacturers of infant formula and 

manufacturers of acidified and low-acid canned foods. These guidelines contain 

recommendations on the frequency of inspections. 

6 FTE data can be found in the FDA FY 2007 Budget Summary and the FY 2010 

Congressional Justification. Available online at 

http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/2007FDABud

getSummary/ucm112799.htm and 

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/U

CM153507.pdf. Accessed on October 2, 2009. 
 

INTRODUCTION 

concerns about staffing, in FY 2009, Congress increased funding for 

FDA’s food program to a level that would support an estimated 

3,019 FTEs.7

During the course of FDA inspections, inspectors from the district 

offices may identify potential violations of the Food, Drug, and Cosmetic 

Act as well as other applicable laws and regulations. Inspectors 

document their findings in a report, which is then reviewed by a 

supervisor and, in some cases, other district officials. Based on the 

outcome of the inspection, the district office assigns the facility one of 

three classifications: official action indicated (OAI), voluntary action 

indicated (VAI), or no action indicated (NAI).8

An OAI classification signifies that the inspector found objectionable 

conditions in the food facility and that these violations potentially 

“warrant regulatory action.”9 This type of violation is the most 

significant identified by FDA 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.”10 An NAI 

classification signifies that the inspector found either no violations of 

Federal law or violations that were so insignificant that no action is 

warranted. 

Under certain circumstances, FDA may change a facility’s inspection 

classification. For example, FDA may modify a classification from OAI 

to VAI if other FDA officials do not concur with the inspector’s initial 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 3

7 FDA, FY 2010 Congressional Justification. Available online at 

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/U

CM153507.pdf. Accessed on October 2, 2009. 

8 FDA, Office of Regulatory Affairs (ORA): Field Management Directive No. 86: 

Establishment Inspection Report Conclusions and Decisions (rev. 06/07/07). Available 

online at 

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061430.htm 

Accessed on June 2, 2009. In addition, under certain circumstances, inspections may also 

be referred to the State when there is either no Federal jurisdiction over the violation in 

question or when it is determined that State action is the most efficient method of obtaining 

compliance. Inspections may also be referred to FDA headquarters when no clear policy has 

been established for the violations or significant technical issues exist which require a 

review and decision. 

9 FDA, ORA Field Management Directive No. 86. Available online at 

http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061430.htm. 

Accessed on June 2, 2009. 

10 Ibid. 
 

OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES 4 

INTRODUCTION

classification. In addition, the classification may be lowered if the 

facility takes, or promises to take, corrective action at some point after 

the inspection. FDA may also raise a classification, for example, if a 

facility promises during an inspection to make corrections and FDA 

subsequently determines that the facility did not make those 

corrections. 

Actions Taken in Response to Violations 

According to FDA guidance, when inspectors uncover violations that are 

significant enough to warrant OAI classifications, some type of 

regulatory action should be recommended.11 This regulatory action 

generally consists of either an advisory action or an enforcement 

action.12 Advisory actions usually allow an opportunity for the facility 

to voluntarily correct the violations found during the inspection, 

whereas enforcement actions are generally initiated in court. 

Enforcement actions generally require facilities to correct the noted 

violations or to destroy adulterated or misbranded products. In some 

cases, an enforcement action may be pursued after a facility’s response 

to an advisory action is deemed to be inadequate. 

Advisory actions. FDA may initiate advisory actions in situations 

involving violations of Federal law. These advisory actions include 

issuing a warning letter or an untitled letter, or holding a regulatory 

meeting.13 These actions allow facilities the opportunity to promptly 

correct the violations found during the inspection. 

FDA may issue a warning letter when it finds violations of Federal law 

that may lead to an enforcement action if the violations are not 

promptly and adequately corrected.14 FDA asks that facilities respond 

to warning letters in writing within a specific timeframe (generally 

within 15 days) to indicate what actions they will take to correct the 

violations.15 FDA guidelines suggest that warning letters be issued 

within 4 months of the last day of the inspection; the date of sample 

11 Ibid. 

12 FDA, Regulatory Procedures Manual, chs. 4, 5, 6, and 10, March 2009. 

13 FDA, Regulatory Procedures Manual, ch. 4 and ch. 10, § 10-3, March 2009. Note that all 

warning letters and untitled letters must be submitted to FDA headquarters for review for 

legal sufficiency and consistency with agency policy. 

14 FDA, Regulatory Procedures Manual, ch. 4, § 4-1-1, March 2009. 

15 FDA, Regulatory Procedures Manual, ch. 4, § 4-1-10, March 2009. 
 

OEI-02-08-00080 FDA I NSPECTIONS OF D OMESTIC F OOD FACILITIES 5 

INTRODUCTION 

analysis; or the date of evidence collection.16 Warning letters are posted 

on FDA’s Internet site. 

FDA may issue an untitled letter when the violations are not significant 

enough to meet the criteria for the issuance of a warning letter.17 

Untitled letters summarize the inspection’s findings but do not include 

a warning statement that failure to make prompt correction may result 

in an enforcement action. They also request that the facility respond 

within “a reasonable amount of time,” such as 30 days.18 Untitled 

letters are not posted on FDA’s Internet site. 

FDA may also request a regulatory meeting with representatives of a 

facility to inform them about how one or more products, practices, 

processes, or other activities are considered to be in violation of the 

law.19 FDA often holds these meetings when violations do not warrant 

the issuance of a warning letter or an untitled letter. However, in 

certain instances, FDA may hold regulatory meetings in conjunction 

with the issuance of a letter to emphasize the significance of the 

violations. 

Enforcement actions. FDA may initiate enforcement actions in situations 

involving violations of Federal law that may not be resolved through 

voluntary compliance. These enforcement actions may include 

administrative detention,20 seizure, injunction, and even prosecution.21 

Depending on the nature of the violations identified, FDA may initiate a 

seizure or an injunction. A seizure often results in adulterated or 

misbranded food being seized and removed from the marketplace. An 

injunction often results in a facility receiving a court order prohibiting 

the production or distribution of a product or forcing the facility to 

16 FDA, Regulatory Procedures Manual, ch. 4, Exhibit 4-1, § 6-1-1, March 2009. 

17 FDA, Regulatory Procedures Manual, ch. 4, § 4-2-1, March 2009. 

18 FDA, Regulatory Procedures Manual, ch. 4, § 4-1-10, March 2009. 

19 FDA, Regulatory Procedures Manual, ch. 10, § 10-3, March 2009. 

20 Although FDA may initiate certain administrative actions, such as administrative 

detentions, such actions are not commonly imposed against food facilities. 

21 FDA, Regulatory Procedures Manual, ch. 4, § 4-1-1, March 2009. FDA may also, under 

certain circumstances, initiate other types of enforcement actions including civil monetary 

penalties and mandatory recalls of infant formula (FDA, Regulatory Procedures Manual, 

ch. 5, § 5-8, and ch. 7, March 2009). 
 

INTRODUCTION 

correct the conditions that caused the violation to occur.22 In general, 

FDA initiates these particular enforcement actions by working with the 

Department of Justice to file a complaint with the U.S. District Court 

where the facility holding the product is located. In addition, under 

certain circumstances, FDA may recommend criminal prosecution to the 

Department of Justice for a food facility or individual who is in violation 

of the law.23

Approaches To Ensure That Violations Are Corrected 

FDA relies on several approaches to determine whether a facility 

corrected the violations found by inspectors. FDA may review evidence 

provided by a food facility describing any completed corrective actions, 

including reports from private consultants detailing corrective actions 

that have been taken. 

In addition, FDA may conduct followup inspections to ensure that 

facilities have corrected the violations. FDA guidelines state that, if 

necessary to ensure that corrections have been implemented, “follow-up 

inspections should be conducted promptly after the agreed upon date of 

completion of the promised corrections.”24 FDA guidelines also suggest 

that facilities receiving OAI classifications be given a higher priority for 

followup inspections.25

Related Reports 

This report is a part of a larger body of work conducted by OIG on food 

safety. In a 2009 report on food traceability, OIG found that 

35 of 40 selected products could not be traced through each stage of the 

food supply chain.26 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 which found that 5 percent of 

selected facilities failed to register with FDA, as required.27

Additionally, that report found that 48 percent of the selected facilities 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 6

22 FDA, Regulatory Procedures Manual, ch. 6, §§ 6-1 (Seizures) and 6-2 (Injunctions), 

March 2009. 

23 FDA, Regulatory Procedures Manual, ch. 5, March 2009. 

24 FDA, Regulatory Procedures Manual, ch. 4, § 4-1-8, March 2009. 

25 FDA, Compliance Program Guidance Manual, ch. 3, pt. II, p. 2. 

26 OIG, Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009. 

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

INTRODUCTION 

either failed to provide accurate information when they first registered 

or after changes in the facilities’ information, as required. 

In another 2009 report, OIG found that FDA does not have statutory 

authority to require manufacturers to initiate pet food recalls and that 

FDA did not always follow its procedures in overseeing pet food 

recalls.28 OIG recommended that FDA consider seeking statutory 

authority to mandate food recalls and to assess penalties for 

noncompliance with the terms of recalls. It also recommended that FDA 

amend its regulations or, if necessary, seek additional legislative 

changes to establish mandatory requirements for facilities to follow in 

conducting recalls. 

METHODOLOGY 

Scope 

This study assesses the extent to which FDA conducted inspections and 

identified violations in domestic food facilities. It also assesses the 

extent to which FDA took action against food facilities with violations 

and ensured that these violations were corrected. 

This study includes inspections of domestic food facilities conducted by 

FDA or by States under contract with FDA. We based this study on 

three sources of data: (1) FDA’s food facility inspection data, (2) FDA 

documentation on facility violations and followup activities, and 

(3) structured interviews with FDA staff. 

Analysis of FDA Food Inspection Data 

To determine the extent to which FDA conducts inspections of domestic 

food facilities, we analyzed data from FDA’s Field Accomplishments and 

Compliance Tracking System (FACTS). FACTS includes information 

about all FDA inspections as well as the classifications for each. 

We requested FACTS data from FDA for all domestic food facility 

inspections for FYs 2004 through 2008. We also requested from FDA 

the number of food facilities within FDA’s jurisdiction each year and 

those that were in business throughout this 5-year period. We analyzed 

these data to determine the percentage of facilities that FDA inspected 

28 OIG, Review of the Food and Drug Administration’s Monitoring of Pet Food Recalls, 

A-01-07-01503, August 2009. Recalls are voluntary actions taken by facilities and are 

therefore not included in our analysis of regulatory actions taken by FDA. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 7
 

INTRODUCTION 

each year and the percentage of facilities that FDA inspected during 

this 5-year period. We also determined the percentage of high-risk 

facilities that FDA inspected each year. We considered a facility to be 

high risk if it had a high-risk designation throughout the entire fiscal 

year. 

In addition, we analyzed FACTS data to determine the extent to which 

FDA identified food facility violations. Specifically, we determined the 

number of facilities that received OAI, VAI, and NAI classifications each 

year. We also used these data to identify the most commonly reported 

violations found in facilities with OAI classifications and the extent to 

which these facilities had a history of violations. 

Review of FDA Documentation 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 8

n 

OAI 

 were not lowered. 

To determine the extent to which FDA took action against food facilities 

with violations and ensured that those violations were corrected, we 

requested from FDA all documentation related to OAI classifications 

received by facilities in FY 2007.29 We chose FY 2007 because it was 

the most current timeframe that would also allow FDA sufficient time

to initiate any actions and to complete any additional activities to 

ensure that the violations were corrected. We requested this 

documentation for all facilities that received OAI classifications, 

including those for which FDA eventually lowered the classification. I

this report, we refer to these as facilities that received “initial 

classifications” to distinguish them from facilities that received OAI 

classifications that

We specifically requested documentation of any advisory actions and 

enforcement actions that FDA initiated that were related to these OAI 

classifications. We also requested documentation of any additional 

inspections and any other activities that FDA conducted to ensure that 

the violations were corrected. FDA provided this documentation for 

actions taken as of April 2009. 

We reviewed the documentation to determine the percentage of facilities 

for which FDA took advisory actions and enforcement actions. We also 

determined the percentage of facilities for which FDA lowered the OAI 

classification and the reasons for these decisions. Lastly, we reviewed 

29 Nineteen facilities had more than one inspection that resulted in an OAI classification in 

FY 2007. In these cases, we requested documentation related to the first inspection that 

occurred in the fiscal year. 
 

INTRODUCTION 

the documentation to determine any additional steps that FDA took to 

ensure that violations were corrected. We conducted this analysis for 

facilities that received OAI classifications that were not lowered by 

FDA. We specifically looked at whether FDA reinspected the facility 

within 1 year of the initial inspection and whether FDA conducted any 

additional followup to ensure that the violations were corrected. As 

noted earlier, FDA guidelines do not specify a timeframe in which 

reinspections must occur; however, for the purposes of our analysis, we 

determined that a year is a reasonable amount of time for FDA to assess 

whether the facilities had promptly and adequately addressed the 

violations found during their inspections. 

Structured Interviews With FDA Officials 

We conducted structured telephone interviews with key staff at FDA 

headquarters and at 10 of the 19 district offices. We selected the 

10 district offices that had the most food facilities within their 

jurisdictions and had conducted the most food facility inspections in 

FY 2007. Our interview questions focused on how the district offices 

classify food facility inspections and under what circumstances they 

choose to take advisory actions and enforcement actions. We conducted 

the interviews with the district offices between September and October 

2008 and with headquarters staff throughout the course of the study. 

Standards 

This study was conducted in accordance with the Quality Standards for 

Inspections approved by the Council of the Inspectors General on 

Integrity and Efficiency. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 9
 

 FINDINGS 

On average, FDA inspects less than a quarter 

of food facilities each year, and the number of 

facilities inspected has declined over time 

Between FY 2004 and FY 2008, FDA 

inspected annually an average of 

24 percent of the food facilities that 

were subject to FDA inspection. 

Except for a few instances, there are currently no specific guidelines 

that govern the frequency with which inspections should occur. As 

shown in Table 1, the percentage of food facilities that FDA inspected 

annually ranged from 29 to 22 percent during this period. 

In addition, the number of food facilities that FDA inspected declined, 

even as the number of food facilities increased. In FY 2004, FDA 

inspected over 17,000 facilities; in FY 2008, this number dropped to 

fewer than 15,000 facilities. During the same period, the number of 

food facilities subject to FDA inspection increased from about 

59,000 facilities to almost 68,000 facilities. FDA officials noted that the 

decline in inspections was largely due to a significant decline in staffing 

levels that resulted from funding cuts. These officials noted that 

between 2003 and 2008, FDA lost almost a quarter of the staff that 

performs food facility inspections. They also noted that many of the 

losses came from the ranks of FDA’s most experienced employees. 

Table 1: Food Facilities Inspected by FDA, FYs 2004–2008 

FY 

Number of Food 

Facilities Subject to 

FDA Inspection 

Number of Food 

Facilities Inspected 

Percentage of 

Food Facilities 

Inspected 

2004 59,305 17,032 29% 

2005 61,930 15,773 25% 

2006 62,929 14,547 23% 

2007 65,520 14,339 22% 

2008 67,819 14,966 22% 

Source: OIG analysis of FDA data, 2009. 

The number of high-risk facilities inspected by FDA has also declined over 

time 

Each year, FDA designates certain facilities as high risk. This 

designation helps FDA determine which facilities should be given a 

higher priority for inspection. As shown in Table 2, the number of 

high-risk facilities that FDA inspected decreased from about 

6,200 facilities in FY 2004 to 5,500 facilities in FY 2008. The 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 10
 

FINDINGS 

percentage of high-risk facilities that FDA inspected annually decreased 

from 77 percent to 63 percent. 

Table 2: High-Risk Food Facilities Inspected by FDA, 

FYs 2004–2008 

FY 

Number of 

High-Risk Food 

Facilities 

Number of 

High-Risk Food 

Facilities Inspected 

Percentage of 

High-Risk Food 

Facilities Inspected 

2004 8,102 6,241 77% 

2005 8,330 5,547 67% 

2006 8,347 5,664 68% 

2007 8,568 5,535 65% 

2008 8,667 5,460 63% 

Source: OIG analysis of FDA data, 2009. 

Further, FDA inspected a smaller percentage of facilities in industries 

that produce certain high-risk food products, such as cheese and 

seafood. For example, in FY 2004, FDA inspected 45 percent of facilities 

in the seafood industry, whereas in FY 2008, FDA inspected only 

32 percent of such facilities. See Appendix A for more information on 

inspections by industry. 

FDA identified 51,229 food 

facilities that were subject to FDA 

inspection and were in business 

from the start of FY 2004 until the end of FY 2008.30 FDA inspected 

only 44 percent (22,531) of these facilities during this 5-year period. As 

shown in Figure 1, 56 percent of these facilities were not inspected at 

all, 14 percent were inspected a single time, and the remaining 

30 percent were inspected two or more times. 

Fifty-six percent of food facilities have gone 5 or 

more years without an FDA inspection 

If FDA does not routinely inspect food facilities, it is unable to 

guarantee that these facilities are complying with applicable laws and 

regulations and that the food handled by these facilities is safe and free 

of disease-causing organisms, chemicals, or other harmful substances. 

30 This excludes facilities within FDA’s jurisdiction that began doing business at some point 

after October 1, 2004, as well as those that went out of business before September 30, 2008. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 11
 

FINDINGS 

Figure 1: 

Number of 

Inspections 

per Food 

Facility 

Between 

FYs 2004 and 

2008 

Source: OIG analysis of FDA data, 2009. 

Facilities Inspected 

Three or More 

Times 

(21%)

Facilities 

Inspected 

Two Times 

(9%)

Facilities 

Inspected

One Time 

(14%)

Facilities Not 

Inspected 

(56%)

N = 51,229

Facilities receive OAI 

classifications when inspectors 

determine that the violations 

found are significant enough to potentially warrant regulatory action, 

such as an advisory action or an enforcement action. As shown in 

Table 3, the number of inspected facilities that received OAI 

classifications decreased from 614 facilities in FY 2004 to 283 facilities 

in FY 2008. The percentage of facilities that received OAI 

classifications also dropped from nearly 4 percent to nearly 2 percent 

during this 5-year period. See Appendix B for additional information on 

the percentage of facilities that received NAI and VAI classifications. 

The number of facilities that received OAI 

classifications has declined over time

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 12
F NDINGS 

Table 3: Food Facilities That Received OAI Classifications, 

FYs 2004-2008 

FY 

Number of Food 

Facilities Inspected 

Number of Food 

Facilities That 

Received OAI 

Classifications 

Percentage of Food 

Facilities Inspected That 

Received OAI 

Classifications 

2004 17,032 614 3.6% 

2005 15,773 511 3.2% 

2006 14,547 432 3.0% 

2007 14,339 304 2.1% 

2008 14,966 283 1.9% 

Note: For FY 2007, we did not include 17 facilities for which FDA officials had incorrectly entered OAI 

classifications in FACTS and 5 facilities that received an OAI classification for a nonfood-related inspection. 

We did not have information on data entry errors for the other years. 

Source: OIG analysis of FDA data, 2009. 

Facilities most commonly received OAI classifications for unsafe food 

manufacturing and handling practices and insanitary conditions in the 

facility 

FDA identified unsafe food manufacturing and handling practices or 

insanitary conditions in 89 percent of the facilities that received OAI 

classifications in FY 2008. 31 Specifically, FDA identified unsafe 

manufacturing and handling practices in 77 percent of these facilities 

and insanitary conditions in 44 percent of these facilities. These types 

of violations could lead to contaminated food products being sold to 

consumers. 

Unsafe manufacturing and handling practices cited by inspectors 

commonly included failure to maintain refrigeration units at safe 

temperatures, inadequate design of manufacturing equipment, and 

improper handling of food products. For example, one inspector found 

that a facility improperly handled its food products by placing ice made 

from contaminated water in direct contact with the food manufactured 

at the facility. Insanitary conditions in the facility often included 

instances of mold or filth or evidence of insects, rodents, or other 

infestations. For example, one inspector observed that pigeons were 

31 A facility may be cited for multiple types of violations during a single inspection. Other 

types of violations found by inspectors included labeling violations and failure to register 

the facility with FDA. 

OEI·02-08·00080 FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES 13 
 

FINDINGS 

flying and roosting above open containers of food in a facility. The 

inspector noted that “bird droppings were observed on equipment” and 

that there were holes in the walls and roof of the facility. 

Nearly three-quarters of the facilities that received OAI classifications in 

FY 2008 had a history of violations 

Seventy-four percent of the facilities that received OAI classifications in 

FY 2008 had a history of violations found during prior inspections. 

Specifically, 63 percent of these facilities received at least one prior VAI 

classification, and 27 percent received at least one prior OAI 

classification. 

In addition, 50 percent of the facilities that received OAI classifications 

in FY 2008 had been cited for the same violation in a prior inspection. 

For example, one facility had already received a warning letter for not 

adequately cleaning its manufacturing equipment, for insanitary 

conditions in the facility, and for labeling violations. The subsequent 

inspection revealed that the facility had failed to correct these 

violations. In another facility, FDA found the same unsafe 

manufacturing practices and insanitary conditions during the previous 

four inspections. After each inspection, the facility promised to make 

corrections but each subsequent inspection revealed that it had not. 

Two percent of the facilities that received OAI classifications refused to 

grant FDA officials access to their records; most of these facilities had a 

history of violations 

Five facilities—four of which had a history of violations—refused to 

provide FDA inspectors with certain requested records. This lack of 

access to records might impede FDA’s ability to determine the most 

appropriate action to take to ensure compliance with applicable laws 

and regulations. These records included descriptions of sanitation 

practices within the facility, lists of customers that received the facility’s 

products, or descriptions of consumer complaints. FDA does not have 

the statutory authority to require food facilities to provide access to 

these records.32

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 14

32 FDA has access to certain records held by infant formula facilities as well as certain 

records needed to trace an article of food through the food supply chain. The limited 

circumstances under which FDA can access these records are described in 

21 U.S.C. §§ 374 and 350. 
 

FINDINGS 

According to FDA guidance, 

when inspectors uncover 

violations that are 

significant enough to 

warrant OAI classifications, 

some type of regulatory 

action should be recommended. This regulatory action generally 

consists of either an advisory action or an enforcement action; however, 

under certain circumstances, FDA may also lower a classification. 

FDA took regulatory action against 46 percent of 

the facilities with initial OAI classifications; for the 

remainder, FDA either lowered the classification or 

took no regulatory action 

In FY 2007, a total of 446 facilities initially received OAI classifications. 

FDA took regulatory action against 46 percent of these facilities. For 

the remainder, FDA lowered the OAI classification for 29 percent and 

took no regulatory action for 25 percent. See Figure 2. 

Figure 2: 

Actions Taken 

After Facilities 

Received OAI 

Classifications, 

FY 2007 

Source: OIG analysis of FDA data, 2009. 

FDA Took 

Regulatory 

Action 

(46%)

FDA Did Not 

Take 

Regulatory 

Action (25%)

FDA Lowered the 

OAI Classification

(29%)

N = 446

Of the facilities that received initial OAI classifications, FDA took advisory 

actions against 44 percent and enforcement actions against 2 percent 

Depending on the severity of the violations and any history of violations, 

FDA may choose to initiate an advisory action or an enforcement action. 

These actions can be taken independently or in combination with one 

another. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 15
 

FINDINGS 

Advisory actions. Of the 446 facilities that received initial OAI 

classifications in FY 2007, FDA took advisory actions against 

44 percent.33 Advisory actions allow an opportunity for a facility to 

voluntarily correct the violations found during the inspection. Advisory 

actions include warning letters, untitled letters, and regulatory 

meetings. 

Specifically, FDA issued warning letters to 20 percent of the facilities 

with initial OAI classifications. In these letters, FDA requested that 

the facilities implement corrective action to remedy the violations. On 

average, FDA took 100 days after the last day of an inspection to issue a 

warning letter; however, for one-third of these facilities, FDA took 

longer than 4 months to issue the warning letters, potentially exceeding 

recommended guidelines. In addition, FDA asked that facilities respond 

in writing within 15 business days of receiving the warning letter; 

however, only 52 percent of these facilities responded within this 

timeframe, and another 26 percent did not respond to FDA at all. 

FDA issued untitled letters to 13 percent of the facilities with initial 

OAI classifications. FDA issues such letters when the violations found 

during an inspection are not determined to be significant enough for the 

issuance of a warning letter. 

In addition, FDA conducted regulatory meetings with 12 percent of the 

facilities with initial OAI classifications. FDA generally holds such 

meetings to encourage voluntary compliance when the violations do not 

warrant the issuance of a letter. For most of these facilities, this was 

the only action taken. 

Enforcement actions. FDA brought enforcement actions against 

2 percent of the facilities that received initial OAI classifications in 

FY 2007. FDA obtained injunctions against seven facilities and seized 

products at three facilities. FDA generally initiates enforcement actions 

in situations involving significant violations of Federal law. For 

example, FDA obtained an injunction after inspecting the same facility 

seven times in 6 years and consistently finding that the facility’s seafood 

products were transported and refrigerated at inadequate 

33 Note that for 2 percent of facilities that received initial OAI classifications, FDA initiated 

multiple advisory actions, such as issuing a warning letter as well as holding a regulatory 

meeting. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 16
 

FINDINGS 

temperatures. In another facility, FDA was able to prevent the sale of 

potentially adulterated food by seizing over 26,000 pounds of rice after 

an inspection revealed a widespread rodent infestation. 

FDA lowered the classification of 29 percent of the food facilities that 

received initial OAI classifications 

As noted earlier, under certain circumstances, FDA may choose to lower 

an inspection classification. FDA lowered the classifications of 

29 percent of the facilities that received initial OAI classifications in 

FY 2007.34 The most common reason that FDA district offices provided 

for lowering the classification was that other FDA district officials did 

not concur with an inspector’s initial classification. The second most 

common reason for lowering the classification was that the facility 

either took or promised to take corrective actions to address violations 

identified during the inspection. In addition, a small number of these 

classifications were lowered because FDA headquarters officials did not 

approve the issuance of a warning letter. 

FDA district offices appeared to be inconsistent in their approach to 

lowering classifications. For example, some district offices did not lower 

their OAI classifications after a facility promised to take corrective action, 

whereas other district offices did this more commonly. Similarly, some 

district offices lowered their OAI classifications when FDA headquarters 

did not approve the issuance of a warning letter, whereas other district 

offices retained the initial OAI classification. Finally, some district offices 

lowered the OAI classifications for which they had already taken 

regulatory action. In many of these cases, FDA reported lowering the 

classifications because the facilities’ response to the action was deemed to 

be adequate. 

FDA took no regulatory action against 25 percent of the food facilities that 

received initial OAI classifications 

Of the facilities that received initial OAI classifications in FY 2007, 

FDA did not take regulatory action against 25 percent. This means that 

FDA did not take either an advisory action or an enforcement action 

against the facilities nor did it lower its initial classification. For over 

half of these facilities, FDA officials noted that they did not issue a 

warning letter due to their interpretation of FDA’s technical guidance. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 17

34 In addition, FDA took regulatory action and then lowered the OAI classifications of 

28 facilities. 
 

FINDINGS 

Specifically, these officials reported that they did not issue a warning 

letter because the time it took the agency to prepare the letter exceeded 

the recommended 4-month timeframe for the issuance of warning 

letters, or because FDA had already issued a warning letter to the 

facility for a prior inspection. In other cases, FDA officials noted that 

they did not take regulatory action because they determined that the 

facilities had adequate plans in place to correct the violations. However, 

for 42 percent of the facilities with no regulatory action, FDA had no 

information about whether the facilities had corrected the violations. 

In FY 2007, 280 facilities 

received OAI classifications 

that were not lowered by 

FDA.35 For 36 percent of 

these facilities, FDA did not reinspect the facilities within a year of the 

inspection or review other evidence provided by facilities to ensure that 

the violations were corrected. If FDA does not ensure that violations 

are corrected in a timely manner, it is unable to guarantee that these 

facilities are complying with applicable laws and regulations and that 

the food handled by these facilities is safe and free of disease-causing 

organisms, chemicals, or other harmful substances. 

For 36 percent of the facilities with OAI classifications in 

FY 2007, FDA took no additional steps to ensure that the 

violations were corrected 

For the remaining facilities, FDA took additional steps to ensure that 

the violations had been corrected. Specifically, FDA reinspected 

35 percent of the facilities within a year of the initial inspection. For an 

additional 30 percent of facilities, FDA reported that it reviewed some 

type of evidence from the facility that demonstrated that the facility had 

corrected violations. Examples of this evidence included photographs 

documenting corrections made in the facility, revised food labels 

documenting changes made to correct labeling violations, or a 

description of how employees were counseled as a means to improving 

food safety. It is important to note, however, that in the absence of 

another inspection, FDA may have been unable to verify whether the 

evidence provided was an accurate and truthful depiction of the 

corrections made by the facility. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 18

35 This excludes nine facilities that went out of business or ceased production. This number 

differs from the number presented in Table 3, possibly because our documentation review 

included classifications that had been lowered as of April 2009, whereas the FACTS data 

included classifications that had been lowered as of July 2008. 
 

FINDINGS 

In addition, for a large number of the facilities that were reinspected, 

FDA continued to find violations of FDA laws and regulations. 

Specifically, in 26 percent of facilities that were reinspected, FDA found 

violations that warranted OAI classifications. In another 47 percent of 

facilities that were reinspected, FDA found violations that warranted 

VAI classifications.

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 19
 

 RECOMMENDATIONS 

Our report found significant weaknesses in FDA’s domestic inspections 

program. Notably, FDA inspects less than a quarter of food facilities 

each year and more than half of all food facilities have gone 5 or more 

years without an FDA inspection. If FDA does not routinely inspect 

food facilities, it is unable to guarantee that these facilities are 

complying with applicable laws and regulations and that the food 

handled by these facilities is safe. 

Our report also found that the number of violations identified in food 

facility inspections has declined over time and that food facilities most 

commonly received violations because FDA inspectors found insanitary 

conditions or unsafe food manufacturing and handling practices. In 

addition, nearly three-quarters of the facilities with OAI classifications 

had a history of significant violations, and some of those facilities 

refused to grant FDA officials access to their records. Because of the 

serious nature of these violations, FDA must take swift and effective 

action to ensure that the violations are remedied. However, we found 

that FDA took no regulatory action against a quarter of facilities with 

initial OAI classifications in FY 2007 and often did not take additional 

steps, such as reinspecting these facilities, to ensure that the violations 

were corrected. 

Taken together, these findings demonstrate that more needs to be done 

to protect public health and to ensure that FDA has the necessary tools 

to prevent outbreaks of foodborne illness. Based on our findings, we 

recommend that FDA: 

Increase the frequency of food facility inspections, with particular emphasis 

on high-risk facilities 

FDA should attempt to inspect a higher proportion of food facilities 

within a 5-year period, as well as inspect a greater number of high-risk 

facilities. As part of this effort, FDA should consider developing 

guidelines for how frequently it should inspect food facilities, 

particularly those that are high risk. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 20
 

RECOMM ENDATIONS 

Provide additional guidance about when it is appropriate to lower OAI 

classifications 

FDA should develop more specific guidance describing when it is 

appropriate to lower OAI classifications. This guidance should 

encourage district offices to be consistent in their approach to lowering 

classifications. Greater consistency in FDA’s approach will help to 

ensure that OAI classifications are adequately addressed and that the 

violations that led to the OAI classifications are remedied. 

Take appropriate actions against facilities with OAI classifications, 

particularly those that have histories of violations 

FDA should take appropriate regulatory action against facilities with 

OAI classifications that are not lowered. Facilities that receive OAI 

classifications have significant violations and FDA should take 

appropriate actions against these facilities. 

In addition, FDA should take stronger actions against facilities that 

have a history of serious violations, particularly those that are cited for 

the same violations multiple times. FDA should also take stronger 

actions against facilities that do not voluntarily comply with requests to 

remedy violations. These actions could range from posting untitled 

letters on the FDA Internet site in situations where facilities fail to 

comply, to initiating a seizure or injunction. 

Ensure that violations are corrected for all facilities that receive OAI 

classifications 

FDA should take steps to ensure that violations are corrected within a 

reasonable amount of time from the initial inspection. Specifically, FDA 

should reinspect facilities that receive OAI classifications or conduct 

other followup activities to verify that the violations are remedied in a 

timely manner. In addition, FDA should develop more specific guidance 

about what steps it should take to ensure that violations are corrected. 

Consider seeking statutory authority to impose civil penalties through 

administrative proceedings against facilities that do not voluntarily comply 

with statutory and regulatory requirements 

Penalties should be levied against facilities that either fail to 

voluntarily correct violations or have a significant history of violations. 

Civil penalties could be an effective method of encouraging facilities to 

comply with statutory and regulatory requirements designed to 

safeguard the Nation’s food supply. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 21
 

RECOMMENDATIONS 

Seek statutory authority to allow FDA access to facilities’ records during the 

inspection process 

This additional authority will help FDA to uncover additional violations 

that may otherwise go undetected and to determine the most 

appropriate actions to remedy those violations. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

In its response to the draft report, FDA noted that it was addressing 

many of the issues and recommendations noted in the report. FDA also 

noted that effective enforcement and compliance with FDA regulations 

will contribute to a stronger food safety system, and that improving the 

speed and predictability of followup to inspections is a top agency goal. 

Specifically, FDA stated that it supported our two recommendations to 

seek additional statutory authority from Congress. It noted that it is 

seeking more effective enforcement tools and that it supports proposed 

legislation to expand civil penalties for food violations and to provide 

additional access to facilities’ records. FDA also agreed with our 

recommendation that it provide additional guidance about when it is 

appropriate to lower OAI classifications and noted that it will revise its 

current guidance. 

For the remaining three recommendations, FDA noted several actions it 

has taken, or plans to take, to address them. FDA stated that it 

received increased appropriations that have permitted it to increase the 

number of food facility inspections. In FY 2009, FDA increased the 

number of field staff for its food program and plans additional increases 

in FY 2010. It also stated that it has taken steps to implement our 

recommendations to ensure that appropriate actions are taken and that 

violations are corrected for all facilities that receive OAI classifications. 

Specifically, FDA noted that it had several new initiatives designed to 

ensure that enforcement actions it takes are swift, aggressive, and will 

have a positive impact on public health. Notably, FDA will make it a 

priority to follow up promptly and with the appropriate action for all 

facilities that receive warning letters. 

FDA will also develop a new warning letter closeout process to ensure 

that all violations are addressed. Additionally, in cases in which FDA 

identifies significant health concerns or other egregious violations, it 

will no longer issue multiple warning letters to noncompliant facilities 

before taking enforcement actions. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 22
 

RECOMMENDATIONS 

We support FDA’s efforts and continue to emphasize the importance of 

FDA taking appropriate and swift action and ensuring that violations 

are corrected in all facilities with OAI classifications. In addition, we 

ask that, in its final management decision, FDA more clearly indicate 

whether it concurs with each of the recommendations listed in the 

report. 

For the full text of FDA’s comments, see Appendix C.

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 23
 

 APPENDIX A 

Table A-1: Facilities Inspected by Industry, Fiscal Years 2004 and 2008 

Top 10 Industries 

Inspected, FY 2008 

Number of 

Facilities 

Inspected in 

FY 2004 

Percentage of 

Facilities 

Inspected in 

FY 2004 

Number of 

Facilities 

Inspected in 

FY 2008 

Percentage 

of Facilities 

Inspected in 

FY 2008 

Fishery/seafood products 3,803 45% 2,927 32% 

Multiple food warehouses 1,575 12% 2,058 16% 

Bakery products 2,230 41% 1,844 24% 

Vegetables and vegetable 

products 1,491 23% 1,590 20% 

Fruit and fruit products 1,321 25% 1,061 15% 

Food services and 

conveyances 1,216 29% 855 22% 

Multiple-food dinners 1,079 40% 816 22% 

Soft drinks and water 755 29% 710 16% 

Cheese and cheese 

products 786 60% 670 28% 

Chocolate and cocoa 

products 427 32% 357 12% 

Note: The top 10 industries inspected were different for FYs 2004 and 2008. 

Source: Office of Inspector General analysis of Food and Drug Administration data, 2009. 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 24
 

 APPENDIX B 

Figure B-1: Percentage of 

Inspected Food Facilities 

by Classification, Fiscal 

Years 2004 and 2008 

Note: If a facility received more than one inspection classification in a year, we counted that facility as having 

received only the most significant classification. 

Source: Office of Inspector General analysis of Food and Drug Administration data, 2009. 

OAI, 2%

OAI, 4%

VAI, 37%

VAI, 41%

NAI, 61%

NAI, 56%

2008

2004

No Action Indicated (NAI)

Voluntary Action Indicated (VAI)

Official Action Indicated (OAI)

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 25
A P PEN D x c 


Agency Comments 

··Food. ~nd. O~~9 .A4~.i~i~~ra.tion 

SHvet~priD9 rilD.20.993 

DATE:··· February 16., 20 10 


TO: lJ1spector General 


Principal Deputy Commissioner ofFood andJ?rugs 


SU.8J:J!;CT:. FDA's (leneraJComlnel~tsto OTO's Draft Report entitled, FDA iJ1.)pe.ctions 


o/DOJ1J{!SlicFoQd Facilities, o.El"02"08"0080· . 


fPAi~·pI:ovid.iilg tJle Attaclwdge~e~:al ~o1l1ments to the OfflcGofInspeC(Of Qeneral's draftrep(lIi 

Glltjtled:i<'DA !mpectiOllS Q/1Jome.stic Food Facilirie.s, OEIcQ2,08-D080. . 

PDf.. appreciptestheopportlUli(y to review and comn}Cuto]1thisdrattrGPoli before it is 

puhlis]lC\l 

Joshu~Sharf.stein,J\lLD... ..... 


Principal Deputy COriHl1iSsiollcrofFood and Drugs 


Attachment 

OEI·02·08·00080 FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES 26 
 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 27

APPENDIX ~ C 
 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 28

APPENDIX ~ C 
 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 29

APPENDIX ~ C 
 

APPENDIX ~ C 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 30
 

OEI-02-08-00080 F D A I NSPECTIONS OF D OMESTIC F OOD FACILITIES 31

APPENDIX ~ A ACKNOWLEDGEMENTS APPENDIX B 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. 

Other principal Office of Evaluation and Inspections staff from the New 

York regional office who contributed to the report include Lucia P. Fort, 

Vincent Greiber, and Bailey Gerstle Orshan; central office staff who 

contributed include Robert Gibbons 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. 

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 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 

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.