The U.S. Food and Drug Administration doesn’t just check food safety inside America-it inspects factories halfway across the world. Every day, food made in China, India, Mexico, and beyond ends up on American shelves. About 15% of the U.S. food supply comes from overseas. That’s not a small number. It’s millions of pounds of produce, spices, seafood, and packaged goods. And if those facilities don’t follow U.S. safety rules, people get sick. That’s why the FDA’s foreign inspection program isn’t optional-it’s essential.

Why Foreign Inspections Changed in 2024

For years, foreign food factories got advance notice before FDA inspectors showed up. They had time to clean up, hire translators, and make sure everything looked perfect. Meanwhile, U.S. factories? No warning. Inspectors walked in unannounced, anytime, day or night. That wasn’t fair. It created a double standard.

In May 2024, the FDA ended that practice. Now, foreign facilities are subject to the same rules as American ones: no advance notice. This wasn’t a small tweak. It was a full reset. FDA Commissioner Martin A. Makary called it a key step to fix a broken system. The goal? To see how a facility really operates-not how it looks when it’s been prepped for a visit.

The change means foreign manufacturers can’t schedule inspections around holidays, vacations, or maintenance windows. They have to be ready every single day. That’s a big shift for companies used to months of warning. But it’s also the only way to catch real problems-like dirty equipment, falsified records, or unsafe practices hidden behind a polished front.

How the FDA Picks Which Factories to Inspect

The FDA doesn’t have enough inspectors to visit all 300,000 registered foreign food facilities every year. So they don’t try. Instead, they use a risk-based system to pick who gets checked.

Three things matter most:

  • What’s being made? Raw seafood, sprouts, and spices carry higher risk than canned beans or bottled water.
  • How’s it made? Processes involving raw ingredients, temperature control, or cross-contamination get flagged.
  • What’s the history? Facilities that’ve had products refused entry before? They’re top priority.
The FDA tracks every refusal, every violation, every complaint. If a factory in Vietnam keeps sending contaminated pepper to the U.S., it’s going on the next inspection list. Fast.

This system is smarter than random checks. It focuses limited resources where they’re needed most. But it’s not perfect. Some low-risk facilities with clean records still get inspected because of random sampling. Others slip through due to data gaps. The FDA is working on better algorithms to predict risk more accurately.

What Happens During an Unannounced Inspection

When an FDA inspector walks into a foreign plant without warning, they’re looking for one thing: real compliance.

They don’t just ask for paperwork. They walk the floors. They watch workers handle food. They check refrigeration units. They open storage bins. They take photos. They interview staff-sometimes without a translator present.

Here’s what they’re checking for:

  • Are surfaces clean and properly sanitized?
  • Are employees wearing gloves, hairnets, and clean uniforms?
  • Is temperature data logged accurately?
  • Are allergens separated to prevent cross-contact?
  • Are records kept in real time-or backdated after the fact?
The FDA doesn’t accept excuses like “we didn’t have a translator ready” or “the manager is on vacation.” If records are missing, if access is blocked, if cameras are turned off-that’s not just a violation. It’s a red flag for criminal investigation.

An FDA inspector in armor views holographic food safety data inside a Thai shrimp plant, one worker hiding records.

The Legal Consequences of Refusing or Obstructing

Under the Federal Food, Drug, and Cosmetic Act, foreign facilities have no legal right to deny, delay, or limit an FDA inspection. That’s not a suggestion. It’s the law.

If a factory refuses entry, the FDA can block all its products from entering the U.S. That’s a financial death sentence for any exporter.

But it gets worse. The FDA can refer cases to the U.S. Department of Justice. If a facility:

  • Deletes digital records
  • Redacts key sections of documents
  • Prevents inspectors from taking photos
  • Shuts down production to hide activities
-then it’s not just a regulatory issue. It’s a criminal one. Companies can face fines, asset seizures, and even debarment from selling to the U.S. market permanently.

Legal experts say the DOJ has prosecuted foreign companies under these rules before. And those cases aren’t going away. The message is clear: obstructing an FDA inspector is a federal crime.

How Foreign Factories Are Adapting

Some companies are struggling. Others are thriving. The difference? Preparation.

Leading exporters now treat every day like inspection day. They’ve hired full-time bilingual quality assurance staff. They’ve installed cloud-based record systems that are accessible 24/7. They run weekly mock inspections with internal teams. They train every employee-down to the warehouse worker-on what FDA inspectors look for.

One facility in Thailand, which exports frozen shrimp to the U.S., now has a “Ready Room” where all inspection documents are stored digitally and backed up in real time. When the FDA showed up unannounced last month, they had access to 18 months of temperature logs, sanitation logs, and employee training records in under 90 seconds.

Smaller operations are having a harder time. Family-run farms or low-budget processors often lack the resources to maintain constant readiness. That’s creating a two-tier system: big companies that can afford compliance, and small ones that risk getting shut out.

The FDA is aware of this gap. But they’re not offering exceptions. The standard is the same for everyone.

A global digital network connects overseas factories to a U.S. FDA command hub, with DOJ agents confronting a corporate saboteur.

What’s Next for FDA Overseas Inspections

The FDA isn’t stopping at unannounced visits. They’re building a smarter system.

Pilot programs are testing third-party inspectors in countries like India and China. These aren’t private auditors. They’re approved, trained, and closely monitored by the FDA. Their reports feed directly into the agency’s risk model.

They’re also rolling out digital inspection tools. Instead of paper checklists, inspectors now use tablets that auto-flag anomalies-like a refrigerator that’s been above 41°F for 4 hours. That data goes straight into a central system that updates compliance scores in real time.

Long-term, the goal is to reduce the need for physical inspections altogether. If a facility consistently scores high on digital monitoring, data from sensors, and supply chain tracking, the FDA might reduce its on-site visits. But if red flags appear? The inspector shows up-with no warning.

What This Means for You

If you buy food in the U.S., you’re benefiting from this system. The peppers in your salsa, the fish in your sushi, the spices in your curry-all of it went through a foreign factory that had to meet U.S. standards. Without these inspections, outbreaks like the 2015 romaine lettuce E. coli crisis or the 2019 salmonella-linked onions would be far more common.

But it’s not perfect. Resource limits mean not every facility gets checked every year. Some gaps remain. Still, the shift to unannounced inspections has already improved compliance. Refusals of imported food dropped by 12% in the first year after the policy change.

The message to foreign manufacturers is simple: Stop preparing for inspections. Start running your facility the right way every day. Because the FDA isn’t coming to check on you. They’re coming to make sure you’re not lying to them.

Do foreign food facilities have to allow FDA inspections?

Yes. Under U.S. law, any foreign facility that exports food to the United States must allow FDA inspections. Refusing entry, delaying inspectors, or limiting access to records or areas is illegal. The FDA can block all shipments from that facility and refer the case to the Department of Justice for criminal prosecution.

Why does the FDA inspect foreign facilities but not always domestic ones?

They do inspect domestic facilities-often without notice. The difference was that foreign facilities used to get advance warning, while U.S. ones didn’t. That changed in 2024. Now, both are treated the same: inspections are unannounced for everyone. The goal is equal enforcement, not preferential treatment.

How often does the FDA inspect foreign food plants?

There’s no fixed schedule. Inspections are risk-based. High-risk facilities (like those making raw seafood or sprouts) or those with past violations may be inspected every year. Low-risk facilities with clean records might go years without one. The FDA aims to inspect at least 600 foreign facilities annually, but the actual number depends on resources and risk priorities.

Can a foreign facility be fined for FDA inspection violations?

Yes. While the FDA can block shipments, criminal violations-like destroying records or obstructing inspectors-can lead to fines, asset forfeiture, and even imprisonment for company officials. The U.S. Department of Justice handles these cases, and foreign companies have been prosecuted before.

What happens if a foreign facility doesn’t speak English?

The FDA doesn’t provide translators during unannounced inspections. Facilities must have staff who can communicate in English or provide their own translation services on demand. Relying on delays for translation is no longer acceptable. Many facilities now employ permanent bilingual quality control staff to avoid issues.