The U.S. Department of Health and Human Services (HHS) has released the results of its study, "FDA Inspections of Domestic Facilities." The purpose of the study from the HHS Office of Inspector General (OIG), was to determine the extent to which the Food and Drug Administration (FDA) conducts inspections of domestic food facilities, identifies violations in food facilities and takes action against those food facilities, and ensures that violations are corrected.
The key findings were:
- 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 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.
According to the report, the study “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 its findings, OIG 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 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.
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:
- supported the two recommendations to seek additional statutory authority from Congress.
- 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.
- agreed with the recommendation to provide additional guidance about when it is appropriate to lower OAI classifications and noted that it will revise its current guidance.
- noted several actions it has taken, or plans to take, to address the remaining three recommendations.
FDA also stated that it received increased appropriations that have permitted it to increase the number of food facility inspections; that it has taken steps to implement the recommendations to ensure that appropriate actions are taken and that violations are corrected for all facilities that receive OAI classifications.
OIG stated that it supports FDA’s efforts and will continue to emphasize the importance of FDA taking appropriate and swift action and ensuring that violations are corrected in all facilities with OAI classifications. It also asked that, in its final management decision, FDA more clearly indicate whether it concurs with each of the recommendations listed in the report.
The full report is available at HHS.