Food safety regulation operates across several connected systems: facility oversight, outbreak investigation, incident response, and controls on a large imported food supply. In 2024, FoodNet sites reported 24,624 infections, while CDC investigated 203 possible multistate enteric outbreaks and FDA’s CORE team evaluated 72 incidents. These figures describe different surveillance and response activities, so they should not be added together.
Contents
- The scale of federal inspection activity
- Where FDA inspections took place
- Registered establishments and regulatory capacity
- What foodborne illness surveillance recorded
- Multistate outbreak investigations
- FDA CORE incident response
- Imported food and regulatory reach
The scale of federal inspection activity
The FDA’s FY 2024 Annual Report on Inspections of Establishments reported 3,128 total inspections of drug and device establishments during fiscal year 2024. This is an establishment-inspection measure, not a count of food inspections or a count of individual products. It is useful for understanding the broader regulatory infrastructure in which food safety oversight sits, but it should not be interpreted as a direct measure of food-facility compliance.
Of those 3,128 inspections, 2,684 were routine surveillance inspections and 453 were for-cause inspections. The report also counted 306 inspections supporting applications and manufacturing-process changes. The categories describe the purpose of the inspection activity: routine surveillance, a response to a cause or concern, and support for applications or process changes.
The same report recorded 206 routine surveillance inspections recognized from foreign regulatory agencies and zero recognized for-cause inspections. Recognition of a foreign-agency inspection is a distinct measure from an FDA inspection performed directly in a region. Keeping the two measures separate matters when comparing domestic activity, overseas activity, and regulatory cooperation.
For a quick view of the reported inspection categories:
| FY 2024 inspection measure | Count |
|---|---|
| Total drug and device establishment inspections | 3,128 |
| Routine surveillance inspections | 2,684 |
| For-cause inspections | 453 |
| Application-support inspections | 306 |
| Foreign-agency routine inspections recognized by FDA | 206 |
| Foreign-agency for-cause inspections recognized by FDA | 0 |
The figures come from the FDA’s FY 2024 Annual Report on Inspections of Establishments. They concern the report’s drug and device establishment program, while the foodborne illness and food-incident measures below come from separate FDA and CDC reporting systems.
Where FDA inspections took place
The geographic distribution reported by FDA shows that the United States accounted for 2,097 of the 3,128 inspections in FY 2024. The report counted 345 inspections in the rest of the world, 234 in the European Union, 206 in China, 205 in India, and 41 in the United Kingdom.
Application-support inspections followed a different geographic pattern. The United States recorded 90, India 69, China 75, the European Union 36, the rest of the world 32, and the United Kingdom 4. These are counts of inspections supporting applications and manufacturing-process changes, not all inspections conducted in each geography.
Routine surveillance accounted for 1,794 inspections in the United States, 311 in the rest of the world, 207 in the European Union, 175 in China, 163 in India, and 34 in the United Kingdom. For-cause inspections included 312 in the United States, 42 in India, 34 in the rest of the world, 31 in China, 27 in the European Union, and 7 in the United Kingdom.
| Geography | Total inspections | Routine surveillance | For-cause | Application support |
|---|---|---|---|---|
| United States | 2,097 | 1,794 | 312 | 90 |
| Rest of the world | 345 | 311 | 34 | 32 |
| European Union | 234 | 207 | 27 | 36 |
| China | 206 | 175 | 31 | 75 |
| India | 205 | 163 | 42 | 69 |
| United Kingdom | 41 | 34 | 7 | 4 |
FDA also recognized 177 routine surveillance inspections in the European Union, 10 in the United Kingdom, 9 in India, 7 in the rest of the world, and 3 in China. These recognized foreign-agency counts are reported separately from the FDA’s direct inspection totals.
Registered establishments and regulatory capacity
The FDA report recorded 9,850 domestic drug establishments and 4,839 foreign drug establishments as of September 30, 2024. The resulting total drug-establishment registration count was 14,689. For medical devices, FDA recorded 14,057 domestic establishments and 16,063 foreign establishments, for a total of 30,120 medical-device-establishment registrations.
These registration figures describe the scale of the establishments in the report’s drug and device categories. Registration is not the same as inspection, enforcement action, or a finding of compliance. It is also measured at a different point from inspection counts, which cover activity during FY 2024.
Across five foreign regions of interest, FDA counted 20,902 registered establishments. The regional counts were 6,829 in China, 4,999 in the European Union, 1,280 in India, 1,516 in the United Kingdom, and 6,278 in the rest of the world.
The report also separated drug establishments by product role. It recorded 4,176 finished drug product establishments, 1,893 active ingredient establishments, and 8,620 other drug establishments in FY 2024. These categories help show why a registration total can contain establishments with different positions in a regulated supply chain.
Funding provides another view of regulatory capacity. FDA’s Office of Regulatory Affairs non-user-fee funding totaled $1,207,102,000 in FY 2024. Of that amount, $348,226,000 supported field medical product programs and $858,876,000 supported field programs for other products. The report said 38.47% of field medical product non-user-fee funding went to domestic and foreign drug and device establishment inspections. Those inspections represented 27.50% of the total ORA budget and 65.97% of field medical product non-user-fee funding.
What foodborne illness surveillance recorded
CDC FoodNet’s 2024 Preliminary Data reported 24,624 infections, 6,746 hospitalizations, and 178 deaths in 2024 across its surveillance sites. The FoodNet figures are surveillance counts for the FoodNet system, not an estimate of every foodborne illness in the United States.
Of the infections, 20,693 were domestically acquired, equal to 84% of all FoodNet infections. Domestically acquired infections accounted for 6,201 hospitalizations, or 92% of all FoodNet hospitalizations, and 164 deaths, or 92% of all FoodNet deaths.
FoodNet’s pre-2023 surveillance area represented 15% of the U.S. population, or about 51 million people. That geographic coverage is important when reading the totals: the figures describe the surveillance area and its definitions, rather than a nationwide count covering every U.S. resident.
Campylobacter was one of the specifically reported pathogens. FoodNet recorded 4,312 Campylobacter infections in 2024, compared with 11,926 in 2023. It recorded 929 Campylobacter hospitalizations in 2024, compared with 2,482 in 2023, and 27 Campylobacter deaths in 2024, compared with 49 in 2023. The source identifies the 2024 figures as preliminary data, so these year comparisons should be read as reported surveillance counts, not as a complete assessment of national disease trends.
Multistate outbreak investigations
CDC’s Summary of Possible Multistate Enteric Disease Outbreaks in 2024 reported 203 possible multistate enteric outbreaks investigated during 2024. CDC confirmed 62 of those multistate outbreaks and solved 45 of the 62, which the summary reported as a 73% solve rate.
The 62 confirmed multistate outbreaks included 29 foodborne outbreaks and 16 animal-contact outbreaks. The categories do not account for all 62 in the supplied summary, so the unlisted cases should not be assigned to a category without additional source information.
Across the 62 confirmed multistate outbreaks, CDC reported 2,605 illnesses, 861 hospitalizations, and 36 deaths. These totals describe illnesses associated with the confirmed multistate outbreak group, not all FoodNet infections or all foodborne illness in the country.
The summary also reported three multistate turtle outbreaks. They caused 77 illnesses, 29 hospitalizations, and zero deaths. Children under 5 accounted for 33% of illnesses in the small-turtle outbreaks. That age-specific percentage applies to the small-turtle outbreak group, not to the entire set of multistate outbreaks.
FDA CORE incident response
FDA’s CORE 2024 Annual Report recorded 72 incidents evaluated by the Coordinated Outbreak Response and Evaluation team in 2024. CORE initiated 26 responses and issued 10 advisories from CORE investigations.
Among 2024 CORE response cases with identified products, vegetables represented 55%, or 11 cases. Multi-ingredient foods represented 20%, or 4 cases. Solid or semi-solid dairy products represented 10%, or 2 cases. Fruits, shell eggs, and nuts and seeds each represented 5%, or 1 case each.
| Product category in identified-product CORE response cases | Share | Cases |
|---|---|---|
| Vegetables | 55% | 11 |
| Multi-ingredient foods | 20% | 4 |
| Solid or semi-solid dairy products | 10% | 2 |
| Fruits | 5% | 1 |
| Shell eggs | 5% | 1 |
| Nuts and seeds | 5% | 1 |
The report said 9 of FDA’s 10 CORE advisories were tied to multistate outbreaks, while 1 advisory was tied to an adverse-event series. CORE evaluations, initiated responses, and advisories are successive but different activity measures; one should not be treated as interchangeable with another.
Imported food and regulatory reach
FDA’s Strategy for the Safety of Imported Food stated that the United States imports about 15% of its overall food supply. More than 200 countries or territories supply food imports to the United States, and roughly 125,000 food facilities plus farms supply imported food.
The imported share is higher for several food categories. Imported supply provides approximately 32% of fresh vegetables consumed annually in the United States, 55% of fresh fruit, and 94% of seafood. These are annual consumption-supply estimates presented by FDA’s strategy document; they are not FY 2024 inspection counts or forecasts of future import levels.
| Imported supply measure | Reported level |
|---|---|
| Overall U.S. food supply | About 15% |
| Fresh vegetables consumed annually | Approximately 32% |
| Fresh fruit consumed annually | 55% |
| Seafood consumed annually | 94% |
| Countries or territories supplying imports | More than 200 |
| Food facilities plus farms supplying imported food | Roughly 125,000 |
Together, these figures explain why food safety regulation must combine domestic oversight with foreign supply-chain controls and outbreak response. They also show why inspection totals alone cannot summarize the system: the regulatory landscape includes registered establishments, recognized foreign inspections, surveillance sites, multistate investigations, incident advisories, and an import network spanning more than 200 countries or territories.