By Jeffrey H. Brochin, J.D.
Although the FDA is on track to meet initial-cycle inspections of domestic food facilities as mandated by the Food Safety Modernization Act (FSMA), since the passage of the Act, overall inspections have plummeted from 19,000 in 2011 to just 16,000 in 2015, and inaccuracies in FDA data have resulted in attempts to inspect facilities which are no longer in business, or which were not in operation at the time of inspectors’ visits, according to a report issued by the Office of Inspector General (OIG). Furthermore, the FDA has relied on the facilities themselves to voluntarily take corrective action when violations have been found (OIG Report, No. OEI-02-14-00420, September 25, 2017).
Background. The 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. As part of its efforts to ensure food safety, the FDA inspects food facilities that manufacture, process, pack, and store food. Investigators from the FDA’s 19 district offices conduct these inspections according to guidance from FDA headquarters. In addition, the FDA contracts with the states to conduct inspections on behalf of the FDA. During the course of FDA inspections, investigators may identify potential violations of the federal Food, Drug, and Cosmetic Act (FDC Act) as well as other applicable laws and regulations. Investigators document their findings and recommend a classification in an inspection report that is reviewed by a district office supervisor and in some cases by other FDA officials.
Impetus behind the FSMA. Each year roughly 48 million people in the United States get sick from foodborne diseases, 128,000 are hospitalized, and 3,000 die. To strengthen the food safety system and better protect public health, Congress passed the FSMA and also amended the FDC Act. The FSMA enabled the FDA to focus more on preventing food safety problems rather than reacting to them after they occur, and towards that end, the FSMA required the FDA to increase the frequency of its inspections of domestic food facilities. The OIG’s review of FDA performance under the FSMA disclosed several deficiencies, and concluded that the FDA has to do more to ensure that the U.S. food supply is safe.
Why the OIG conducted the review. The recent review builds on food safety work conducted by the OIG that identified weaknesses in the FDA’s food inspection program. In a 2010 review, the OIG found that the FDA inspected less than a quarter of domestic food facilities each year, and that many facilities had not been inspected in 5 years or more. To date, FDA has not implemented two key recommendations from OIG’s 2010 review: (1) taking appropriate action against facilities with significant inspection violations and (2) ensuring that those facilities correct the violations. The objectives of this report were: (1) to assess whether the FDA is on track to meet the inspection timeframes for domestic food facilities mandated by the FDA Food Safety Modernization Act, (2) to determine whether the inspection mandates increased the overall number of domestic food facilities the FDA inspected, and (3) to determine the extent to which the FDA takes action in response to violations found during domestic food facility inspections.
How the OIG conducted the review. The OIG analyzed data from four sources: (1) information about facilities that the FDA designated high risk and non-high risk pursuant to the FSMA, and whether those facilities were inspected as required; (2) the FDA’s food facility inventory and inspection data from 2010 to 2015; (3) information about the FDA actions such as warning letters and seizures taken in response to significant inspection violations, as well as whether follow up inspections were conducted for these violations; and (4) structured interviews with FDA officials.
Disturbing findings. The OIG review determined that although the FDA is on track to meet the domestic food facility inspection timeframes for the initial cycles mandated by the FSMA, challenges remain because the FSMA requires the FDA to conduct future inspections in timeframes that are two years shorter than the timeframes for the initial cycles. Inaccuracies in the FDA’s domestic food facility data have resulted in the FDA attempting to inspect numerous facilities that were either out of business or otherwise not in operation at the time of the visit.
Furthermore, the overall number of food facilities that the FDA inspected since the passage of the FSMA has decreased from a high of about 19,000 facilities in 2011 to just 16,000 facilities in 2015. But perhaps most disturbing is the finding that the FDA did not always take action when it uncovered significant inspection violations—those found during inspections classified as "Official Action Indicated" (OAI)—and, when it did take action, it commonly relied on the inspected facilities to voluntarily correct the violations. Also, it rarely took advantage of the new administrative tools provided by the FSMA. Moreover, the FDA’s actions were not always timely nor did they always result in the correction of violations. In addition, the FDA consistently failed to conduct timely follow up inspections to ensure that facilities corrected significant inspection violations. In fact, for almost half of the significant inspection violations, the FDA did not conduct a follow up inspection within one year; for 17 percent of the significant inspection violations, FDA did not conduct a follow up inspection of the facility at all.
OIG recommendations. The OIG auditors recommended that the FDA: (1) improve how it handles attempted inspections to ensure better use of resources, (2) take appropriate action against all facilities with significant inspection violations, (3) improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions, and (4) conduct timely follow up inspections to ensure that significant inspection violations are corrected. The FDA concurred with all four recommendations.
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