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 made in America. It watches over food made anywhere that ends up on American shelves. About 15% of everything we eat comes from overseas-fruits from Mexico, spices from India, seafood from Vietnam, supplements from China. And if you’re running a facility that ships food to the U.S., you’re now under a new kind of watch. No more warning calls. No more time to clean up, retrain staff, or hide problems. Starting in 2024, the FDA began conducting unannounced inspections at foreign food plants-just like they’ve always done in the U.S.

Why the Change? Ending the Double Standard

For years, foreign facilities got advance notice-sometimes weeks ahead-so they could arrange translators, clean the facility, and make sure the right people were on-site. Meanwhile, American plants got no warning at all. The FDA inspectors showed up when they wanted, checked the real conditions, and left. That wasn’t fair. And it wasn’t safe.

In May 2024, FDA Commissioner Martin A. Makary made it clear: "We’re ending a double standard." If you’re making food for Americans, you’re held to the same standard as a plant in Ohio or California. No special treatment. No head start. If you’re not ready at 8 a.m. on a Tuesday, you’re not ready at all.

The goal? Prevent foodborne illness before it hits U.S. soil. The FDA doesn’t want to find contaminated peanut butter or tainted spices after they’ve already been sold. They want to catch the problem at the source.

Who Gets Inspected-and How They Pick You

Not every one of the 300,000 registered foreign food facilities gets inspected every year. The FDA doesn’t have enough inspectors for that. Instead, they use a risk-based system to decide who gets visited next.

Three things matter most:

• What you make-High-risk foods like raw seafood, sprouts, or infant formula get higher priority than canned beans or baked goods.
• How you make it-Processes that involve raw ingredients, multiple handling steps, or temperature-sensitive controls are riskier than sealed packaging or pasteurization.
• Your record-If your products have been denied entry into the U.S. before, or if you’ve had past violations, you’re on the list. The FDA tracks every refusal, every warning letter, every complaint.

The law (FSMA, passed in 2011) required the FDA to double foreign inspections every year for five years. That push is still in motion. And now, with unannounced visits, the stakes are higher than ever.

What Happens During an Unannounced Inspection

You won’t know they’re coming. One day, you’ll see two FDA inspectors at your gate. They’ll show ID. They’ll ask to enter. And if you say no-you’ve already broken the law.

Once inside, they’ll:

• Walk through every part of your facility-production, storage, packaging, waste areas.
• Ask to see your records: sanitation logs, training files, supplier approvals, test results.
• Observe your workers in real time-no rehearsed routines, no "inspection mode".
• Take photos or videos if they suspect violations.
• Interview staff directly, without your managers present.

They’re not there to be nice. They’re there to find problems. And they’re trained to spot them-even if you don’t speak English.

What Gets You in Trouble

It’s not just about dirty floors or expired ingredients. The FDA is looking for systemic failures. Here’s what triggers enforcement:

• Delaying or denying access-Holding inspectors outside while you "call your lawyer" is illegal.
• Limiting observation-Blocking them from seeing a machine, a storage room, or a worker’s hands is a violation.
• Redacting records-Crossing out parts of logs, hiding batch numbers, or refusing to show electronic files counts as obstruction.
• Interrupting production-Telling workers to stop working so the inspectors can’t see what’s really happening? That’s a red flag.
• Refusing to allow photography-If an inspector wants to take a picture of a broken seal or a contaminated surface, you can’t say no.

These aren’t minor offenses. The U.S. Department of Justice can pursue criminal charges against foreign companies that obstruct inspections. Fines, asset forfeiture, and even exclusion from the U.S. market are possible outcomes.

How to Prepare-Without Warning

If you’ve been relying on advance notice to get ready, you’re behind. The new rule is simple: Be ready every day.

Here’s what top-performing foreign facilities are doing now:

• Keep records digital and always accessible-Cloud-based systems with real-time backups. No more paper files locked in a drawer.
• Hire bilingual QA staff-Not temporary translators. Full-time employees who understand FDA regulations and can explain procedures on the spot.
• Run monthly mock inspections-Have someone pretend to be an FDA inspector. No warning. Just show up with a clipboard and start asking questions.
• Train every employee-Not just managers. Cleaners, packers, machine operators-they all need to know what to do if an inspector walks in.
• Never accept help from the facility-The FDA now bans inspectors from accepting rides, meals, or lodging from the companies they inspect. That means you can’t "make it easier" by offering a taxi or a hotel. Don’t try.

The goal isn’t to impress. It’s to prove you’re always compliant. Not just when you know someone’s coming.

The Real Challenge: Resources and Fairness

The FDA’s ambition is clear: become the global gold standard for food safety oversight. But they’re still stretched thin. With 300,000 foreign facilities and only a few hundred inspectors, that’s roughly one inspector for every 1,500 plants.

That’s why risk-based targeting matters. A small family-run spice grinder in rural India has a different risk profile than a large seafood processor in Vietnam exporting to Walmart. The FDA knows this. They’re using data, not luck, to decide who gets checked.

Still, critics argue the system isn’t fair. Small businesses struggle to afford the digital systems, bilingual staff, and constant training. Meanwhile, big companies with global compliance teams adapt quickly. The result? A two-tiered system-where only the well-funded can truly stay compliant.

The FDA says they’re working on solutions: using third-party inspectors under FDA supervision, building AI tools to flag high-risk facilities, and expanding partnerships with foreign regulators. But for now, the burden falls on the facility.

What Happens If You Fail?

If the FDA finds serious violations during an inspection, they can:

• Issue a Form 483-A list of observed deficiencies. You get 15 days to respond.
• Issue a Warning Letter-A formal notice that you’re in violation of U.S. law.
• Refuse entry of your products-Your shipment gets turned away at the border.
• Place your facility on Import Alert-Your products are automatically detained without physical inspection.
• Refer your case to the DOJ-For criminal prosecution.

Once you’re on Import Alert, getting removed is hard. You need to prove-through multiple successful inspections-that you’ve fixed everything. And you’ll be watched even more closely after that.

The Bigger Picture: Global Standards Are Rising

The FDA isn’t alone. The European Union, Japan, Canada, and Australia are all tightening their own foreign inspection rules. But the FDA’s shift to unannounced inspections has become a model.

If you want to sell food to the U.S., you’re not just complying with local laws. You’re complying with the strictest, most unpredictable inspection regime in the world. And if you can pass FDA standards, you can probably pass any other country’s.

This isn’t about punishment. It’s about protection. Every unannounced inspection is a chance to stop a contaminated product before it reaches a child’s lunchbox or an elderly person’s dinner plate.

Final Thought: Compliance Isn’t a Project. It’s a Culture.

You can’t outsource food safety. You can’t hire a consultant to fix it for a month. Real compliance means building a culture where every person on the floor knows what to do, every record is accurate, and every process runs the same way-whether the FDA is there or not.

The days of preparing for inspections are over. The new rule is simple: Be ready. Always.