FDA Foreign Facility Inspections: What Overseas Food Plants Must Now Do to Stay Compliant

The U.S. Food and Drug Administration doesn’t just watch over food factories in Ohio or California. It also inspects over 300,000 foreign facilities that ship food to American shelves. And since May 2024, those inspections no longer come with a heads-up.

Why the FDA Stopped Giving Foreign Facilities Advance Notice

For years, foreign food plants got weeks or even months to prepare for an FDA visit. They cleaned up, trained staff, arranged translators, and made sure paperwork was perfect. Meanwhile, American factories got no warning at all. That wasn’t fair-and it wasn’t safe.

In early 2024, FDA Commissioner Martin A. Makary called it a "double standard." If a U.S. plant can’t hide problems by cleaning up before an inspection, why should a plant in India, China, or Mexico get that luxury? Starting in May 2024, the FDA began conducting unannounced inspections at foreign facilities just like it does at home.

The goal? To catch real conditions, not staged ones. A facility might look flawless when it knows inspectors are coming. But what happens when they walk in without warning? That’s when you see if the quality control system actually works every day-or just on inspection days.

What Gets Inspected and How the FDA Picks Targets

Not every foreign plant gets checked every year. The FDA uses a risk-based system to decide who gets visited next. Three things matter most:

• What’s being made-Raw seafood, sprouts, and infant formula carry higher risk than canned beans or bottled water.
• How it’s made-Processes with more steps, more handling, or less heat treatment are more likely to harbor pathogens.
• History of violations-If a facility has had products refused entry into the U.S. before, it’s now on the FDA’s watchlist.

The FDA doesn’t just show up randomly. It uses data from past inspections, import alerts, and lab test results to build a risk profile for each facility. A plant in Vietnam that’s shipped 12 rejected shipments of spices in the last year? That’s top priority. A facility in Germany that’s never had a problem? It might go years without a visit.

What Happens During an Unannounced Inspection

When FDA inspectors arrive, they don’t ask for a tour. They show their badge and start asking for records-right then. They want to see:

• Sanitation logs from the past 6 months
• Supplier approval records
• Employee training files
• Product testing results
• Corrective action reports for past issues

They’ll walk through production areas, watch how equipment is cleaned, check if raw ingredients are stored properly, and even take swabs for lab testing. They’re allowed to take photos. They’re allowed to interview workers-even without a translator present.

Here’s the catch: if a facility delays, denies, or limits access-like refusing to let inspectors see a room, hiding documents, or only giving partial records-it’s not just a warning. It’s a criminal offense under U.S. law.

The Legal Consequences of Refusing or Obstructing

Under Section 306 of the FDA Food Safety Modernization Act (FSMA), any foreign facility that refuses inspection can have its products barred from entering the U.S. That’s not a fine. That’s a full stop to sales.

But it gets worse. If a company deliberately obstructs an inspection-by shredding documents, blocking access, or telling staff not to talk to inspectors-the U.S. Department of Justice can press criminal charges. That means:

• Fines up to $1 million per violation
• Forfeiture of assets tied to the violation
• Reparations to victims of foodborne illness
• Debarment from doing business with U.S. companies
• Exclusion from federal healthcare programs

These aren’t theoretical penalties. In 2023, the DOJ prosecuted a Chinese seafood processor for falsifying temperature logs and refusing to show inspection records. The company paid over $800,000 in fines and was barred from exporting to the U.S. for five years.

How Foreign Facilities Are Adapting

Many overseas manufacturers are scrambling to adjust. Some are hiring full-time bilingual quality assurance staff just to handle inspections. Others are moving all documentation to cloud-based systems so inspectors can access records instantly, no matter the time zone.

One facility in Thailand now runs monthly mock inspections with internal auditors who act like FDA agents-showing up without notice, demanding files, and recording responses. They even simulate language barriers by asking questions in broken English to see how staff react.

The biggest shift? No more "inspection prep week." You can’t clean up for a day and call it good. You have to be ready every day. That means:

• Sanitation logs updated in real time
• Staff trained to answer questions without coaching
• Equipment maintained consistently, not just before scheduled visits
• Records backed up and accessible 24/7

The Bigger Picture: Why This Matters for U.S. Consumers

About 15% of the food Americans eat comes from overseas. For fresh produce, that number jumps to 32%. That means a lot of your salad, spice, seafood, and baby food was made somewhere else.

Before FSMA, the FDA inspected only a tiny fraction of foreign facilities. In 2018, ProPublica found that foreign inspections had dropped to historic lows due to budget cuts. That created blind spots in the food supply chain.

Today, the FDA is trying to close those gaps. The unannounced inspection policy isn’t about punishing foreign companies. It’s about leveling the playing field. If a U.S. plant can’t cheat its way through an inspection, neither should a foreign one.

What Happens If You Fail an Inspection?

Failing an inspection doesn’t mean your products are automatically banned. But it does trigger a series of consequences:

• Warning letter-The FDA sends a formal notice listing violations. You have 15 days to respond with a corrective plan.
• Import alert-Your products are flagged at U.S. ports. Every shipment gets automatically detained until you prove it’s safe.
• Re-inspection-The FDA may return within 30-90 days to check if you fixed the problems.
• Refusal of entry-If you don’t fix the issues, your shipments are turned away at the border.
• Public listing-Your facility’s violations are posted on the FDA’s public website.

Once you’re on an import alert, it can take months to get removed-even after fixing the problem. And once you’re flagged, buyers in the U.S. start avoiding you. Reputation damage can be worse than fines.

Is the FDA Doing Enough?

The FDA still faces a massive challenge. With over 300,000 foreign facilities and only about 200 inspectors assigned to international inspections, the ratio is roughly 1 inspector per 1,500 facilities. Even with unannounced visits, they can’t cover them all.

To make up the gap, the FDA is testing new tools:

• Third-party auditors certified by the FDA to conduct inspections on its behalf
• AI-powered risk models that analyze global supply chain data in real time
• Remote document reviews using secure digital portals

But none of these replace the value of an inspector walking through a facility, seeing how workers handle equipment, or noticing a dirty floor in a corner no one thinks to clean.

What You Need to Do If You Export Food to the U.S.

If your facility ships food, supplements, or animal feed to the U.S., here’s what you need right now:

1. Make sure your FDA registration is current and accurate.
2. Ensure your facility has a written food safety plan that meets 21 CFR Part 117 (Current Good Manufacturing Practice).
3. Train all staff on how to respond to unannounced inspections-no scripts, no coaching.
4. Keep all records digital, backed up, and accessible from any device.
5. Assign a point person who’s always available to receive inspectors.
6. Conduct monthly internal mock inspections with no notice.

Don’t wait for an inspector to show up. If you’re not ready today, you’re already behind.