Behind the FDA’s Work to Inspect Food Facilities

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The Food and Drug Administration (FDA) inspects food facilities to check that they follow safety rules. The stakes are high: each year, roughly 48 million people in the United States get sick from foodborne diseases and 3,000 die. The law sets inspection timeframes of three or five years for domestic facilities, depending on risk, but a 2025 inspector general report found gaps in FDA’s efforts to meet them.

When an inspection finds problems, FDA can leave the facility with a written list of conditions its investigators believe may violate the law, known as a Form 483. That list is not the agency’s final legal determination. FDA weighs the company’s response and other evidence before deciding what to do next; this article explains that process, how to read a public inspection record and where to report a food problem.

Which food facilities the FDA inspects

FDA regulates food in interstate commerce except meat, poultry and certain processed egg products overseen by the U.S. Department of Agriculture (USDA).

Facilities that manufacture, process, pack or hold food for human or animal consumption in the United States generally must register with FDA before beginning those activities. The registration rules exempt establishments including farms, restaurants, retail food businesses and private residences where FDA-regulated food is made. The exemption is from registering with FDA; an exempt business may still be overseen by another regulator. State, local and tribal authorities primarily oversee restaurants, grocery stores and other retail food establishments; FDA supports them with model rules, training and technical assistance.

Federal law allows FDA to count domestic inspections performed by other federal, state or local agencies under agreements, contracts or similar arrangements. The inspector carrying out federal oversight need not be an FDA employee.

For imports, FDA uses foreign facility inspections alongside importer verification, border examinations and sampling, seeking the same standards as for domestic food. The business bringing food into the country has checking duties of its own. Under the Foreign Supplier Verification Programs rule, a covered importer must verify that its foreign suppliers provide the same level of public health protection as the rules on preventing food hazards and on safely growing and handling produce, as applicable, and that the food meets legal safety requirements and required allergen labeling. To do that, the importer must evaluate food hazards and supplier performance, approve suppliers, carry out verification and take corrective action, and it needs written procedures governing approved suppliers.

Why one facility gets inspected before another

Federal law directs FDA to allocate inspection resources according to risk, considering the hazards of the food, a facility’s compliance history, including recalls and outbreaks, and the effectiveness of its own controls for preventing hazards, among other criteria.

The FDA Food Safety Modernization Act requires that each high-risk domestic facility be inspected at least once every three years. For domestic facilities not identified as high risk, the required interval is at least once every five years. These are legal inspection requirements, not a claim that every facility receives its visit on time.

Infant formula manufacturers have a separate annual inspection requirement under the Food and Drug Omnibus Reform Act of 2022.

FDA sorts inspections by purpose. Surveillance inspections assess a facility’s compliance or focus on an emerging food-safety trend. Compliance follow-up inspections check corrections after earlier violations, problematic samples or agency action. For-cause inspections address particular problems such as outbreaks, consumer complaints or recalls, and FDA often expedites them.

Federal law authorizes designated officers who present credentials and a written notice to enter a facility at reasonable times and to inspect it within reasonable limits and in a reasonable manner. For domestic facilities, FDA’s policy says a lawful inspection at a reasonable time, within reasonable limits and in a reasonable manner does not require company consent; refusing after identified officers present official notice can expose the person responsible to criminal penalties. FDA says food from a foreign establishment that refuses an inspection can be refused entry into the United States, and failure to respond to an inspection notice may count as refusal.

In a May 6, 2025, announcement, FDA said it intends to expand unannounced inspections of foreign facilities that make food and other products. A statement quoted in the announcement said foreign companies had been given advance notice of inspections while American manufacturers were held to standards “with no such warning.” FDA later reported that unannounced inspections rose from 47 percent to 87 percent of the total at its India office and from 19 percent to 61 percent at its China office between fiscal 2025 and fiscal 2026 to date, a shift it tied particularly to countries supplying critical drugs. Those figures are totals for each office, not broken out for food, and do not establish that every foreign food facility receives surprise visits.

What investigators look for inside a facility

Investigators interview management, review prior corrections, watch production, examine records and speak with employees to see whether procedures are being implemented. A written policy and a working practice are different things; the inspection compares them.

Under FDA’s preventive-controls rule for human food, covered facilities must have and follow a written food safety plan that includes a hazard analysis, preventive controls and procedures for monitoring, corrective action and verification. The plan connects the hazard to the action meant to control it, rather than treating cleanliness as an isolated checklist.

Depending on the food and facility, preventive controls include process controls, allergen controls, sanitation controls, supply-chain controls, a recall plan and other necessary procedures.

Allergen cross-contact means an unintended food allergen enters a food. Sanitation controls for covered facilities must address cleaning food-contact surfaces and preventing allergen cross-contact and cross-contamination, including contamination carried by personnel or equipment. Personnel working directly with food, food-contact surfaces or packaging must follow hygienic practices that protect against contamination and allergen cross-contact.

The manufacturing rules also require equipment and utensils to be adequately cleanable and maintained, and to avoid contaminating food with materials such as lubricants, metal fragments or dirty water.

Covered facilities must establish written monitoring procedures and check preventive controls frequently enough to assure that the controls are consistently performed. Verification checks include whether monitoring occurs, whether corrective decisions are appropriate and whether controls work, with activities documented in records. Monitoring follows the control as it operates; verification tests whether that checking system and its decisions can be relied on.

Corrective-action procedures must identify and fix a control problem, reduce recurrence when necessary, evaluate affected food and keep it out of commerce when its legally required safety cannot be assured.

The full written-plan requirement is not universal. A business that meets the definition of a “qualified facility” is subject to modified requirements: it attests to FDA that it qualifies and either that it is controlling the hazards in its food or that it complies with non-federal food-safety law, such as state or local rules.

A qualified facility is either a very small business or a business that meets two tests. The business must sell more food directly to consumers, or to nearby restaurants and stores that sell to consumers, than to all other buyers, and its total food sales must stay under a limit. A very small business is one averaging less than $1 million a year, adjusted for inflation, over the preceding three years in human-food sales plus the market value of food it handled without selling. Small size alone does not establish that a business meets the rule’s conditions.

During inspections, FDA may collect environmental samples with sterile sponges or swabs from food-contact surfaces and places such as floors and drains to detect harmful bacteria. FDA may target that sampling because of illness or recall history, unsanitary conditions, inadequate environmental monitoring or a pathogen found in a product sample. Checking a drain or a conveyor can reveal a contamination pathway that looking at the finished package would miss.

What happens after an inspection finds problems

Investigators issue Form FDA 483 to management at the end of an inspection when they observe conditions that, in their judgment, may violate the governing law. FDA considers those observations along with a written report called an Establishment Inspection Report, evidence collected on site and the company’s response before deciding what further action is appropriate.

For foreign food facilities, FDA encourages a written response with supporting documentation within 15 business days after the closeout meeting, a discussion with management at the conclusion of the inspection. FDA’s general inspection manual also tells investigators to explain that an adequate response within 15 business days after the inspection ends may affect whether further action is needed, including for domestic facilities. A response is an opportunity to demonstrate a repair; submitting one does not itself establish that the repair worked.

FDA classifies a finished inspection using these terms.

• No action indicated (NAI) means investigators found no objectionable conditions or practices during the inspection.
• Voluntary action indicated (VAI) means objectionable conditions or practices were found, but FDA is not prepared to take or recommend administrative or regulatory action.
• Official action indicated (OAI) means regulatory or administrative actions are recommended.

These classifications describe FDA’s response to an inspection, rather than giving every product from a facility a permanent safety rating.

When FDA identifies what it believes are significant violations, it may issue a warning letter identifying concerns and requesting a response, then check whether the corrections are adequate.

Under its mandatory-recall authority, FDA acts when it determines there is a reasonable probability that a food other than infant formula is adulterated or misbranded in its allergen labeling, and that using or being exposed to it will cause serious adverse health consequences or death. Adulterated is a legal term that includes food unfit to eat or produced under unsanitary conditions that could contaminate it or make it harmful. A routine inspection observation does not automatically meet that standard. When the standard is met, FDA must first give the responsible party an opportunity to stop distribution and recall the food voluntarily. If the responsible party does not stop distribution or recall the food as requested, FDA may order distribution stopped and recipients notified, then require a recall or other appropriate action if removal is necessary after an opportunity for a hearing within two days of the initial order.

FDA may suspend a facility’s registration when food it handled has a reasonable probability of causing serious adverse health consequences or death. The suspension can reach a facility that caused or was responsible for that risk, or one that knew or had reason to know of it and packed, received or held the food. While a registration is suspended, no one may import or export food from that facility or otherwise introduce it into interstate or intrastate commerce in the United States.

Why the inspection system still misses risks

In its 2025 domestic-inspection report, the Department of Health and Human Services’ Office of Inspector General found that FDA had missed required domestic inspection timeframes and was conducting fewer food-facility inspections than before the pandemic. The inspector general also found wasted attempts at facilities that were not operating and a lack of timely follow-up inspections for most significant violations.

A January 8, 2025, report by the Government Accountability Office (GAO) examined fiscal years 2018 through 2023 and found foreign inspections far below the annual target of 19,200. The highest foreign total in that period was 1,727 in fiscal 2019, about 9 percent of the target; FDA called the target unrealistic but had not identified and communicated an appropriate replacement to Congress.

FDA officials told GAO that nearly one-quarter of the 432 investigators on board in July 2024 were eligible to retire, that fully training a new investigator takes about two years, and that outbreak responses divert resources from routine inspections.

GAO’s report made recommendations to FDA; as of June 2026, GAO listed the one on avoiding unsuccessful inspection attempts as implemented, while recommendations on the size of the foreign-investigator workforce and on a process for managing inspection performance remained open. FDA had introduced procedures to check whether domestic facilities were operating before an unannounced visit and launched a foreign-inspection workgroup, but reported no detailed update on the performance-management recommendation. Checking that a facility is operating can save a wasted trip; it does not show that food-safety outcomes improved.

The oversight question has two parts: whether FDA reaches facilities as required and whether the resulting work produces timely, verified corrections.

How to read an inspection record or report a problem

FDA’s searchable inspection records include facility names and addresses, inspection dates, types of regulated products and final inspection classifications. Start with the facility and the date, then read the classification as the outcome of that particular inspection.

FDA says the classification dashboard is updated weekly and adds inspections once they are classified and closed; it excludes state inspections and inspections waiting for final enforcement action, among other categories. A missing entry cannot be treated as proof that a facility has never been inspected. A favorable older entry also cannot establish the condition of a production line today.

For a medical emergency, FDA says to call 911; if you think you have food poisoning, CDC says to talk to your healthcare provider and report the illness to your local health department. For a particular product concern, reporting the problem is more useful than waiting to interpret a facility’s inspection history. FDA directs non-emergency food complaints from consumers, health professionals and industry members, except complaints about meat or poultry, to Consumer Complaint Coordinators or electronic or paper Voluntary MedWatch forms. A worker reporting a production problem and a consumer reporting a purchased product can both supply information that prompts a closer look.

FDA directs complaints about meat or poultry to USDA’s Meat and Poultry Hotline at 1-888-674-6854. The Centers for Disease Control and Prevention directs suspected foodborne illness reports to local health departments, which track illnesses to identify outbreaks.

FDA asks complainants to state what happened, provide contact details, describe the product and its label codes, and identify the store and date of purchase. Product codes connect a concern to a specific item instead of leaving investigators with only a brand name.

Restaurant food and sanitation fall primarily under state, local and tribal oversight. Direct a restaurant concern to the relevant state, local or tribal authority rather than assuming the federal factory-inspection system handles it.

A public inspection record can show what government found at a facility; a detailed complaint can give government a reason to investigate something it has not yet seen.