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

Every bite of imported food you eat - whether it’s coffee from Colombia, spinach from Mexico, or seafood from Vietnam - passed through a U.S. Food and Drug Administration inspection before it reached your plate. But since May 2024, the rules changed. The FDA no longer gives foreign food factories advance notice before showing up to inspect them. That’s right: no heads-up, no time to clean up, no last-minute translation help. If you’re running a food plant overseas that ships to the U.S., you’re now expected to be ready every single day.

Why the FDA Stopped Giving Advance Notice

For years, foreign food facilities got weeks or even months to prepare for an FDA visit. They’d schedule inspectors’ flights, hire translators, and make sure everything looked perfect. Meanwhile, U.S. factories got no warning at all. The FDA called it a double standard - and they were done with it.

In May 2024, FDA Commissioner Martin A. Makary made it official: foreign inspections would now match U.S. standards. That means surprise visits. No exceptions. The goal? To catch real conditions, not staged ones. If a facility only cleans up before an inspection, you’re not seeing how it actually runs. And that’s dangerous.

The FDA inspects about 15% of the U.S. food supply that comes from abroad. That’s over $100 billion worth of food every year. With 300,000 registered foreign facilities and only a few hundred inspectors, they can’t check them all. So they focus on the biggest risks: facilities with past violations, those making high-risk foods like sprouts or seafood, or those in countries with weak oversight.

What the FDA Checks During an Inspection

When an FDA inspector walks into your facility, they’re not just looking for dirt. They’re checking if your entire system meets U.S. food safety rules under the Federal Food, Drug, and Cosmetic Act. Here’s what they look for:

Good Manufacturing Practices (GMPs): Are workers washing hands? Are surfaces cleaned regularly? Are pests kept out?
Recordkeeping: Can you pull up temperature logs, sanitation schedules, or supplier approvals in under 10 minutes?
Process controls: Do your cooking, chilling, or pasteurization steps actually work? Can you prove it?
Facility conditions: Are there cracks in walls? Is water safe to drink? Is the drainage working?
Documentation access: Can the inspector see all digital records without redactions? Can they take photos?

The FDA doesn’t just ask for paperwork. They walk through your production line. They watch how you handle raw ingredients. They check your refrigerated storage. They test your water. And if you try to hide anything - like blocking a camera, refusing to hand over records, or turning off a machine during inspection - that’s a federal crime.

The New Rules: What You Can’t Do During an Inspection

The FDA’s Investigations Operations Manual spells it out clearly. You can’t:

Delay or deny access to any part of the facility
Limit where inspectors go or what they see
Redact or alter records during inspection
Refuse to let inspectors take photos or videos
Interrupt production to hide problems
Offer lodging, meals, or transportation to inspectors

The last one matters. Before 2024, many foreign facilities paid for inspectors’ hotels and taxis. Now, that’s forbidden. It’s not about being rude - it’s about avoiding any appearance of bias. If the FDA thinks you’re trying to win them over, they’ll see it as interference.

Violations aren’t just fines. The U.S. Department of Justice can press criminal charges. Companies have been fined millions. Executives have been barred from doing business with the U.S. market. And if your facility refuses inspection, your products get blocked at the border - permanently.

FDA inspector reviews digital records in a sprout facility with automated systems and visible compliance issues.

Who’s Most at Risk?

Not all foreign plants are treated the same. The FDA uses a risk-based system to pick who gets inspected. Here’s what pushes you to the top of the list:

High-risk products: Raw sprouts, shellfish, nut butters, infant formula, or ready-to-eat meals that don’t get cooked again
History of refusals: If your shipments got rejected in the past, you’re flagged
Country risk: Facilities in countries with weak food safety systems get more attention
Compliance history: Past violations, warning letters, or recalls

Small family-run operations are hit hardest. They often lack full-time quality staff, digital records, or bilingual employees. Big companies? They’ve hired compliance teams, installed cloud-based record systems, and run monthly mock inspections. The gap is growing.

How Foreign Facilities Are Adapting

Some factories are still struggling. Others have figured it out. Here’s what works:

24/7 digital records: Cloud-based systems that let inspectors access logs remotely - no USB drives, no printed binders
Permanent bilingual staff: Someone who speaks English and understands FDA terminology - not a hired translator
Monthly surprise audits: Train your team like they’re being inspected every day
Clear inspection protocol: Who answers the door? Who calls the legal team? Who handles records?
Third-party audits: Hiring ISO-certified auditors to check your system before the FDA shows up

One seafood processor in Vietnam started doing weekly internal inspections after three shipments got rejected. Within six months, they went from a 40% refusal rate to zero. They now ship to Walmart, Target, and Whole Foods.

Foreign executive faces legal consequences as FDA inspection footage projects in a U.S. courtroom.

What Happens If You’re Not Ready?

If the FDA finds violations, they issue a Form 483 - a list of observations. It’s not a fine. It’s a warning. But if you ignore it, or if they find the same problem again, you get a warning letter. Then comes detention: your products are held at the border. No entry. No appeal.

Worse? If you refuse inspection, your facility is automatically barred from exporting to the U.S. under Section 306 of FSMA. That’s it. No second chance. No negotiation. Your entire U.S. market is gone.

And if you lie, hide records, or obstruct inspectors? The DOJ can charge your company with a felony. That means fines, asset seizures, and executives banned from the industry.

The Bigger Picture: Why This Matters

The FDA isn’t just checking boxes. They’re protecting American families. In 2023, 20% of foodborne illness outbreaks linked to imported food came from facilities with known compliance issues. That’s preventable.

This shift is also changing global standards. Countries like Canada and the EU are watching. If the FDA can make 300,000 foreign factories operate at U.S. levels, others will follow. The pressure is on for the entire global food supply chain to get cleaner, faster, and more transparent.

For manufacturers, this isn’t about fear. It’s about trust. If you want to sell to the U.S., you have to prove you’re not cutting corners. And now, you have to prove it without warning.

What You Need to Do Today

If you run a foreign food facility that ships to the U.S., here’s your checklist:

Review your FSMA compliance status - are you registered and certified?
Ensure all records (temperature logs, sanitation logs, supplier certificates) are digital and instantly accessible
Hire at least one permanent English-speaking quality manager who understands FDA expectations
Conduct monthly unannounced internal inspections - no warning, no prep
Train every employee on what to do if FDA shows up - no panic, no lies, no hiding
Never offer inspectors rides, meals, or lodging - it’s illegal
Know your facility’s inspection history - if you’ve had refusals, fix the root cause now

The FDA doesn’t want to shut you down. They want you to do it right. But they’re no longer waiting for you to get ready. You’re already late if you’re still thinking this is optional.

Do foreign food facilities still get advance notice from the FDA?

No. Since May 2024, the FDA no longer gives advance notice to foreign food facilities. All inspections are unannounced, matching the same standard applied to U.S. facilities. This change was made to ensure inspections reflect real, everyday operations - not staged conditions prepared after a warning.

What happens if a foreign facility refuses an FDA inspection?

If a foreign facility refuses, delays, or limits an FDA inspection, the agency can legally refuse admission of all products from that facility into the United States under Section 306 of the FSMA. The facility is placed on an import alert, meaning every future shipment is automatically detained at the border. Reinstatement requires a full re-inspection and proof of corrective actions - which can take months or years.

Can the FDA criminally charge a foreign company for obstructing an inspection?

Yes. The U.S. Department of Justice can pursue criminal charges against foreign companies that obstruct FDA inspections. This includes actions like redacting records, blocking camera access, interrupting production to hide issues, or refusing to provide documents. Convictions can lead to fines, asset forfeiture, and exclusion from doing business with the U.S. market.

How often does the FDA inspect foreign food facilities?

The FDA is required by law to increase foreign inspections annually. Since the Food Safety Modernization Act (FSMA) passed in 2011, inspections have doubled each year for five years. Today, the agency inspects only a small fraction of the 300,000 registered foreign facilities - focusing on high-risk facilities, those with past violations, or those in countries with weaker food safety systems. The goal is risk-based targeting, not universal coverage.

What types of food are most likely to be inspected?

High-risk foods are prioritized, including raw sprouts, shellfish, nut butters, infant formula, ready-to-eat meals, and fresh produce. These products are more likely to carry pathogens like Listeria, Salmonella, or E. coli. Facilities producing these items, especially those with past refusals or in countries with weak oversight, are inspected more frequently.

Can a foreign facility hire a translator for an FDA inspection?

Yes, but only if the translator is permanently employed by the facility and available at all times. The FDA no longer allows facilities to hire temporary translators on the day of inspection. The expectation is that key personnel - including quality and compliance staff - must be fluent in English to communicate directly with inspectors without delay or misinterpretation.

Do I need to provide lodging or meals to FDA inspectors?

No. FDA inspectors are required to pay for their own lodging, meals, and transportation. Offering these benefits is strictly prohibited and considered a conflict of interest. If a facility provides any form of hospitality to inspectors, it could be viewed as an attempt to influence the inspection and may lead to enforcement action.