Testimony of:  
Jodi Nudelman 
Regional Inspector General for Evaluation and Inspections 
Office of Inspector General, U.S. Department of Health & Human Services  
_________________________________________________________________________________  
 
Good afternoon, Chairman Stupak, Ranking Member Burgess, and other distinguished Members of 
the Subcommittee.  I am Jodi Nudelman, Regional Inspector General for Evaluation and Inspections 
of the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG).  I 
appreciate the opportunity to appear before you to discuss our oversight work as well as the vital role 
that the Food and Drug Administration (FDA) plays in protecting the Nations food supply. 
 
Recent high-profile outbreaks of foodborne illness have underscored the importance of food facility 
inspections.  My testimony today will focus on my offices recent review of FDAs inspection 
program.1  In short, our report identifies significant weaknesses in FDAs inspections of domestic 
food facilities.  We found that many food facilities went 5 or more years without an FDA inspection.  
We also found that there was a large decline in the number of food facility inspections conducted by 
FDA over a 5-year period, 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.   
 
Our recent report is a part of a larger body of OIG work that demonstrates that more needs to be done 
to ensure the safety of the Nations food supply.   In a report on food traceability, we found that only 
5 of 40 selected products could be traced through each stage of the food supply chain.2   In addition, 
more than half of the facilities that handled these food products failed to meet FDA recordkeeping 
requirements.  In another report, we found that 5 percent of selected facilities failed to register their 
facilities with FDA as required.  Of those facilities that did register, almost half failed to provide 
accurate information in FDAs registry.3  Finally, we completed a report that found that FDA did not 
always follow its procedures when overseeing certain pet food recalls and noted that FDA does not 
have the statutory authority to mandate recalls.4   
 
OIGS MISSION IS TO PROTECT HHS PROGRAMS AND BENEFICIARIES   
 
OIG is an independent, nonpartisan agency committed to protecting the integrity of the more than 
300 programs administered by HHS as well as the health and welfare of the people served by them.  
OIG fights fraud, waste, and abuse through a nationwide network of investigations, audits, and 
evaluations, as well as enforcement and compliance activities.  
 
OIGs work results in recoveries of misspent or stolen funds and in recommendations for program 
savings and improvements to program efficiency and effectiveness.  In FY 2009, OIG investigations 
 
1 OIG, FDA Inspections of Domestic Food Facilities, OEI-02-08-00080, April 2010.   
2 OIG, Traceability in the Food Supply Chain, OEI-02-06-00210, March 2009.   
3 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires certain food facilities to 
register with FDA.  The purpose of registration is to provide FDA with reliable information that enables FDA to quickly locate 
facilities during outbreaks of foodborne illness.  See OIG, FDAs Food Facility Registry, OEI-02-08-00060, December 2009.   
4 OIG, Review of the Food and Drug Administrations Monitoring of Pet Food Recalls, A-01-07-01503, August 2009.   
1  House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations:  Hearing 
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  resulted in $4 billion in settlements and court-ordered fines, penalties, and restitution.  OIG audits 
resulted in almost $500 million in expected recoveries.  OIG also produced equally important but less 
quantifiable gains in deterrence and prevention of fraud, waste, and abuse and in improved program 
operations.  Additionally, OIG has raised awareness of critical issues among policymakers, 
Government agencies, and other relevant stakeholders.  Moving forward, OIG is committed to 
building on our successes and continuing to protect the integrity of Government programs and their 
beneficiaries.  
 
FOOD FACILITY INSPECTIONS ARE AN IMPORTANT TOOL TO ENSURE FOOD 
SAFETY  
 
Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming 
contaminated foods and beverages.5  FDA is responsible for safeguarding the Nations food supply 
by ensuring that food is free of disease-causing organisms, chemicals, or other harmful substances.6  
Recent outbreaks, such as the salmonella outbreak caused by insanitary conditions at a peanut- 
processing plant in 2009as well as others that resulted in large recalls of spinach, peppers, and 
alfalfa sproutshave raised questions about FDAs inspections process and its ability to protect the 
Nations food supply. 
 
FDA inspects food facilities to ensure food safety.  During an FDA inspection, an inspector may 
identify potential violations of the Food, Drug, and Cosmetic Act or other applicable laws and 
regulations.  Based on the outcome of the inspection, FDA assigns the facility one of three 
classifications:  official action indicated (OAI), voluntary action indicated, or no action indicated. 
 
According to FDA guidance, when inspectors uncover violations that are significant enough to 
warrant OAI classification, FDA should consider taking some type of regulatory action.  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 usually initiated in court and the facility is 
compelled to correct the violations found during the inspection. 
 
Once an FDA inspection finds violations at a facility, FDA uses several methods of determining 
whether a facility has subsequently corrected the violations.  FDA may review evidence of corrective 
actions provided by a food facility or FDA may reinspect a facility to verify that corrections were 
made. 
 
OIG ASSESSED THE FREQUENCY AND RESULTS OF FDAS FOOD FACILITY 
INSPECTIONS 
                                                                                                                                                                                           
Our study assessed the extent to which FDA conducted inspections and identified violations in 
domestic food facilities.7  It also assessed the extent to which FDA took regulatory action against 
food facilities with violations and ensured that these violations were corrected.   
 
5 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. 
6 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.   
7 This study includes inspections of domestic food facilities conducted by FDA or by States under contract with FDA. 
2  House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations:  Hearing 
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We based our study on three sources of data:  (1) FDAs data on food facility inspections, (2) FDAs 
documentation of facility violations and followup activities, and (3) structured interviews with FDA 
staff.   
 
To determine the extent to which FDA conducts inspections, we analyzed FDAs data on all 
domestic food facility inspections for fiscal years (FY) 2004 through 2008.  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.  We chose FY 2007 because it was the most recent timeframe that would also 
allow FDA sufficient time to initiate any actions and to complete any activities designed to ensure 
that violations were corrected. 
 
MOST FOOD FACILITIES WENT UNINSPECTED FOR AT LEAST 5 YEARS 
 
Our study found that 56 percent of food facilities that were subject to FDA inspection went 5 or more 
years without an FDA inspection.  If FDA does not routinely inspect food facilities, it is unable to 
ensure that these facilities are complying with applicable laws and regulations and that the food 
handled by these facilities is safe.  Except in a few instances, there are currently no specific 
guidelines that govern the frequency with which inspections should occur.   
 
Our study also found that the number of food facility inspections has declined, even as the number of 
food facilities has increased.  In FY 2004, FDA inspected more than 17,000 facilities; in FY 2008, 
this number dropped to fewer than 15,000.  During the same period, the number of food facilities 
subject to FDA inspection increased from about 59,000 to almost 68,000 facilities.  We also 
identified a decline in the number of high-risk facilities inspected by FDA.8   
 
FDA officials attributed the decline in inspections primarily to a significant decrease 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 
those losses came from the ranks of FDAs most experienced employees. 
 
THE FREQUENCY OF VIOLATIONS IDENTIFIED BY FDA INSPECTIONS DECLINED, 
AND MOST FACILITIES WITH VIOLATIONS WERE REPEAT OFFENDERS  
 
Facilities receive OAI classifications when inspectors determine that the violations found are 
significant enough to potentially warrant regulatory action.  Facilities most commonly received OAI 
classifications for unsafe food manufacturing and handling practices and insanitary conditions in the 
facilities, such as improper handling of food or evidence of rodent infestations.   
 
From FY 2004 to FY 2008, the percentage of inspected facilities that received OAI classifications 
dropped from nearly 4 percent to less than 2 percent.  Further, over this 5-year period, the number of 
facilities with OAI classifications declined from 614 facilities to 283 facilities.   
 
 
8 Each year, FDA designates certain facilities as high risk.  This designation helps FDA determine which facilities should be 
given a higher priority for inspection.  Generally, these facilities handle types of food that have a greater potential to cause 
harm. 
3  House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations:  Hearing 
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  Our study also found that nearly three-quarters of the facilities that received OAI classifications in 
FY 2008 had a history of violations.  Even more worrisome, half of the facilities that received OAI 
classifications had been cited for exactly the same violations in prior inspections.  In one notable 
example, FDA found that a facility had the same unsafe manufacturing practices and insanitary 
conditions as it did during the previous four inspections.  After each inspection, the facility promised 
to make corrections; however, each subsequent inspection revealed that nothing had changed. 
 
We also found that a small number of facilities refused to grant FDA officials access to records 
during an inspection.  These records included descriptions of sanitation practices within each facility, 
lists of customers that received the facilitys products, and descriptions of consumer complaints.  
FDA does not currently have the statutory authority to require food facilities to provide access to 
these records.9   
 
FDA DID NOT TAKE REGULATORY ACTION AGAINST MANY FACILTIES WITH 
VIOLATIONS 
 
According to FDA guidance, when a facility receives an OAI classification, FDA should consider 
taking some type of regulatory action.  This regulatory action generally consists of either advisory 
action or enforcement action.  In FY 2007, FDA took advisory actions against 44 percent of the 446 
facilities that initially received an OAI classification, whereas FDA initiated enforcement actions 
against 2 percent of these facilities.10 
 
FDA lowered the classifications of 29 percent of the facilities that initially received OAI 
classifications.  The most common reason for lowering a classification was that other FDA officials 
did not concur with the inspectors initial classification.  The second most common reason for 
lowering a classification was that the facility either took or promised to take corrective actions.  
Although FDA guidelines allow inspection classifications to be lowered, FDA district offices 
appeared to be inconsistent when 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.     
 
For 25 percent of facilities initially receiving OAI classifications, FDA neither took any regulatory 
action against the facilities nor lowered the classifications.  In just over half of these cases, FDA 
officials noted that they did not take regulatory action because of their interpretation of FDAs 
program guidance.  For example, FDA guidelines suggest that multiple warning letters should not be 
issued for the same violations.   Several officials reported that they did not issue a warning letter 
because FDA had previously issued a warning letter to the facility. 
 
FDA OFTEN DID NOT TAKE SWIFT AND EFFECTIVE ACTION TO ENSURE THAT 
VIOLATIONS WERE REMEDIED 
 
FDA often failed to follow up with facilities to ensure that violations were corrected.  In FY 2007, 
280 facilities received OAI classifications that were not lowered by FDA.  FDA did not reinspect 36 
 
9 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.   
10 The advisory actions taken by FDA consisted of warning letters, untitled letters, and regulatory meetings.  The 
enforcement actions taken by FDA consisted of seizures and injunctions. 
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  percent of these facilities within a year of the inspection or review evidence 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 facilities demonstrating that they had corrected the violations.11  Examples of this 
evidence included photographs documenting corrections made in the facility, revised food labels 
documenting changes made to correct labeling violations, and a description of how employees were 
counseled.   
 
OIG RECOMMENDS SEVERAL ACTIONS TO STRENGTHEN FDAS DOMESTIC 
INSPECTIONS PROGRAM 
 
Based on these findings, we made six recommendations to FDA to improve its domestic inspections 
program.  Specifically, we recommended 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 a history of violations; 
  ensure that violations are corrected for all facilities that receive OAI classifications; 
  seek statutory authority to allow FDA access to facilities records during the inspection 
process; and 
  consider seeking statutory authority to impose civil penalties through administrative 
proceedings. 
IN CONCLUSION, MORE NEEDS TO BE DONE TO PROTECT THE SAFETY OF THE 
NATIONS FOOD SUPPLY 
 
Our report identified significant weaknesses in FDAs inspections program.  If FDA does not 
routinely inspect food facilities, it is unable to ensure that these facilities are complying with 
applicable laws and regulations and that the food handled by these facilities is safe.  In addition, FDA 
must take swift and effective action to ensure that all violations are remedied.  Taken together, the 
findings of this report 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. 
 
OIG recognizes the importance of ensuring the safety of the food supply and will continue our work 
in this area.  We are currently conducting a review that assesses FDAs oversight of inspections 
conducted by State inspectors under contract.  In addition, we are conducting an audit of selected 
 
11 Note that these percentages do not sum to 100 percent because of rounding. 
5  House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations:  Hearing 
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  food recalls to determine whether FDAs oversight was adequate to ensure that the recalls were 
complete, accurate, and timely.     
This concludes my testimony.  I welcome your questions. 
 
6  House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations:  Hearing 
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