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IINNSSPPEECCTTOORR  GGEENNEERRAALL  
 
 
 
 
 
 
 
 
FDA INS  PECTIONS OF DOMESTIC 
 
F F  
OOD  ACILITIES
 
   
 
 
 
 
 
 
 
 
 
 
 
 
  Daniel R. Levinson  
Inspector General 
 
 
  April 2010  
OEI-02-08-00080 
   
   
 
 E X E C U T I V E   S U M M A R Y  
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 
FDAs inspections process and its ability to protect the Nations 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 facilitys 
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 INSPECTIONS OF DOMESTIC FOOD FACILITIES  i     
   
 
E X E C U T I V E   S U M M A R Y  
We based this study on three data sources:  (1) FDAs 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 INSPECTIONS OF DOMESTIC FOOD FACILITIES  ii     
   
 
  E X E C U T I V E   S U M M A R Y  
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 FDAs 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 INSPECTIONS OF DOMESTIC FOOD FACILITIES  iii     
   
 
E X E C U T I V E   S U M M A R Y
   
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 FDAs 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. 
  OEI-02-08-00080    FDA  I NSPECTIONS OF  DOMESTIC FOOD FACILITIES   iv      
   
 
 T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
 
I N T RO DUC T IO N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 
 
F I N D IN G S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 
 
R E C O MMEN D A T ION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 
 
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 
  OEI-02-08-00080   FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES  0     
   
 
 I N T R O D U C T I O N  
 
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 Nations 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 FDAs inspections process and its ability to 
protect the Nations 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. 607625.  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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    1 
   
   
 
I N T R O D U C T I O N  
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 FDAs 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, FDAs 
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 
 
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. 
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I N T R O D U C T I O N  
concerns about staffing, in FY 2009, Congress increased funding for 
FDAs 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 facilitys inspection 
classification.  For example, FDA may modify a classification from OAI 
to VAI if other FDA officials do not concur with the inspectors initial 
 
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 INSPECTIONS OF DOMESTIC FOOD FACILITIES    3 
   
   
 
I N T R O D U C T I O N   
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 facilitys 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  INSPECTIONS OF  DOMESTIC FOOD FACILITIES   4  
   
   
 
I N T R O D U C T I O N   
analysis; or the date of evidence collection.16  Warning letters are posted 
on FDAs 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 inspections 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 FDAs 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). 

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I N T R O D U C T I O N  
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 FDAs 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 
 
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, FDAs Food Facility Registry, OEI-02-08-00060, December 2009.  
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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) FDAs 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 FDAs 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 FDAs 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 Administrations 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.   
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I N T R O D U C T I O N  
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 
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.  In 
this report, we refer to these as facilities that received initial OAI 
classifications to distinguish them from facilities that received OAI 
classifications that were not lowered. 
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.  
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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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    9 
   
   
 
 F I N D I N G S  
On average, FDA inspects less than a quarter  Between FY 2004 and FY 2008, FDA 
of food facilities each year, and the number of  inspected annually an average of       
24 percent of the food facilities that 
facilities inspected has declined over time  
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 FDAs most experienced employees.   
Table 1:  Food Facilities Inspected by FDA, FYs 20042008  
Number of Food  Percentage of 
Facilities Subject to  Number of Food  Food Facilities 
FDA Inspection  Facilities Inspected  Inspected 
FY 
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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    10 
   
   
 
F I N D I N G S  
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 20042008   
Number of      Number of      Percentage of 
High-Risk Food  High-Risk Food  High-Risk Food 
Facilities   Facilities Inspected  Facilities Inspected 
FY 
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 
Fifty-six percent of food facilities have gone 5 or 
facilities that were subject to FDA 
more years without an FDA inspection 
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.  
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 FDAs 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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    11 
   
   
 
F I N D I N G S  
Figure 1:  
Facilities Inspected 
Number of  
Three or More 
Inspections  Times  
per Food  (21%) 
Facility 
Between  
FYs 2004 and  Facilities 
Facilities Not  
Inspected 
2008   Inspected  
Two Times  
(56%) 
(9%) 
Facilities 
Inspected
One Time  N = 51,229
(14%)
 
  Source:  OIG analysis of FDA data, 2009. 
 
 
 
Facilities receive OAI 
The number of facilities that received OAI 
classifications when inspectors 
classifications has declined over time 
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. 
 
 
 
 
 
 
 
 
 
 
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    12 
  F  NDINGS 
Table 3:  Food Facilities That Received OAI Classifications, 
FYs 2004-2008 
Number of Food  Percentage of Food 
Facilities That  Facilities Inspected That 
Number of Food  Received OAI  Received OAI 
Facilities Inspected  Classifications  Classifications 
FY 
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 
ofviolations 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 ofviolations during a single inspection. Other 
types of violations found by inspectors included labeling violations and failure to register 
the facility with FDA. 
OEI02-0800080  FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES  13   
   
 
F I N D I N G S  
 
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 facilitiesfour of which had a history of violationsrefused to 
provide FDA inspectors with certain requested records.  This lack of 
access to records might impede FDAs 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 facilitys 
products, or descriptions of consumer complaints.  FDA does not have 
the statutory authority to require food facilities to provide access to 
these records.32 
 
 
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. 
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    14 
   
   
 
F I N D I N G S  
According to FDA guidance, 
FDA took regulatory action against 46 percent of 
when inspectors uncover 
the facilities with initial OAI classifications; for the 
violations that are 
remainder, FDA either lowered the classification or  significant enough to 
took no regulatory action   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.  
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 
FDA Lowered the 
After Facilities  OAI Classification
Received OAI  (29%) 
Classifications, 
FY 2007 
  FDA Took 
Regulatory 
Action 
(46%) 
FDA Did Not 
Take 
Regulatory 
Action (25%) 
N = 446
  Source:  OIG analysis of FDA data, 2009. 
 
 
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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    15 
   
   
 
F I N D I N G S  
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 facilitys 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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    16 
   
   
 
F I N D I N G S  
 
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 inspectors 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 FDAs technical guidance.  
 
34 In addition, FDA took regulatory action and then lowered the OAI classifications of        
28 facilities.   
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    17 
   
   
 
F I N D I N G S  
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 
For 36 percent of the facilities with OAI classifications in  
received OAI classifications 
FY 2007, FDA took no additional steps to ensure that the 
that were not lowered by 
violations were corrected 
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 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.   
 
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. 
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    18 
   
   
 
F I N D I N G S  
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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    19 
   
   
 
 RR EE CC OO MM MM EE NN DD AA TT II OO NN SS   
 
 
Our report found significant weaknesses in FDAs 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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    20 
   
   
 
R E C O M ME N D A T I O N S  
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 FDAs 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 Nations food supply.   
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    21 
   
   
 
R E C O M M E N D A T I O N S  
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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    22 
   
   
 
R E C O M M E N D A T I O N S  
We support FDAs 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 FDAs comments, see Appendix C.
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    23 
   
   
 
 A P P E N D I X   A  
 
Table A-1:  Facilities Inspected by Industry, Fiscal Years 2004 and 2008 
Number of  Percentage of  Number of  Percentage 
Facilities  Facilities  Facilities  of Facilities 
Top 10 Industries  Inspected in   Inspected in   Inspected in   Inspected in 
Inspected, FY 2008  FY 2004  FY 2004  FY 2008  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     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    24 
   
   
 
 A P P E N D I X   B  
 
Figure B-1:  Percentage of 
Inspected Food Facilities 
by Classification, Fiscal 
 
Years 2004 and 2008  NAI, 61% VAI, 37% OAI, 2%
 
2008
 
NAI, 56% VAI, 41% OAI, 4%
2004
 
No Action Indicated (NAI)
 
Voluntary Action Indicated (VAI)
 
Official Action Indicated (OAI)  
 
   
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. 
 
 
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    25 
  x  c 

A  P  PEN  D 
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  Attaclwdge~e~:al ~o1l1ments 
tJle  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 
OEI020800080  FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES  26   
   
 
A P P E N D I X   ~   C  
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A P P E N D I X   ~   C  
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    28 
   
   
 
A P P E N D I X   ~   C  
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AA PP PP EE NN DD II XX    ~~    CC   
 
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A P P E N D I X   ~   A  
 AAA PCC PKK ENN NOO DWW ILLXEE  DDB GG  ME ME NE NT ST  S  
 
This report was prepared under the direction of Jodi Nudelman, 
Regional Inspector General for Evaluation and Inspections in the New 
York regional office, and Meridith Seife, Deputy Regional Inspector 
General.   
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. 
 
OEI-02-08-00080     FDA INSPECTIONS OF DOMESTIC FOOD FACILITIES    31 
   
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.