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 food facilities in more than 150 countries that ship products to American shelves. About 15% of the food Americans eat comes from overseas - including 32% of fresh produce. And since 2024, the rules for these foreign plants have changed dramatically. No more advance notice. No more warning calls. If the FDA shows up, you’re being inspected - right then, no prep time.

Why the FDA Changed the Rules

For years, foreign food manufacturers got a heads-up before FDA inspectors arrived. They’d schedule inspections weeks in advance, hire translators, clean up the facility, and get staff ready. Meanwhile, American plants were often hit with surprise visits - no warning, no preparation. That wasn’t fair. It created a loophole. Facilities could look perfect during inspections while cutting corners the rest of the time.

In May 2024, FDA Commissioner Martin A. Makary called it a "double standard." The agency announced it would start treating foreign facilities the same way it treats U.S. ones: unannounced inspections only. The goal? To catch real conditions, not staged ones. If a plant can’t maintain safe practices every day, it shouldn’t be allowed to export to the U.S.

This isn’t just about fairness. It’s about safety. In 2018, ProPublica found that FDA inspections of foreign facilities had dropped to historic lows due to budget cuts. That meant dangerous products could slip through. Now, the FDA is trying to rebuild trust - and protect consumers - by making inspections unpredictable and strict.

How the FDA Picks Which Plants to Inspect

The FDA doesn’t inspect every single foreign facility. With 300,000 registered plants and only a few hundred inspectors, they have to be smart about it. They use a risk-based system that looks at three things:

• What’s being made? Raw seafood, sprouts, and powdered infant formula are high-risk. Canned beans or bottled water are lower risk.
• How’s it made? Processes that involve raw ingredients, multiple handling steps, or lack of pasteurization raise red flags.
• What’s the history? If a facility’s products have been refused entry into the U.S. before - especially multiple times - it’s top of the list.

The FDA also tracks refusal rates. If a shipment gets turned away at the border because of contamination, poor labeling, or unsanitary conditions, that facility gets flagged. Repeat offenders? They’re likely to get an unannounced visit within months.

What Happens During an Unannounced Inspection

When FDA inspectors arrive at a foreign plant, they don’t ask for coffee. They show their credentials, state their purpose, and begin. Here’s what they look for:

• Documentation: Records must be available immediately - no waiting for IT to retrieve files. That includes sanitation logs, supplier approvals, training records, and test results.
• Facility conditions: Cleanliness, pest control, proper storage temperatures, and separation of raw and finished products are checked on the spot.
• Process controls: Inspectors watch how food moves through the plant. Can they see the entire process? Are there blind spots?
• Employee behavior: Are workers following hygiene rules? Are they trained? Do they know what to do if something goes wrong?

The FDA has the legal right to take photos, collect samples, and review any record related to food safety. They’re not allowed to accept rides, meals, or lodging from the facility. That’s new. In the past, companies would arrange everything for inspectors. Now, the FDA pays for its own travel. The goal? To avoid any appearance of favoritism.

What Gets You in Trouble - Even If You’re Not Breaking the Law

You might think if your facility is clean and your food is safe, you’re fine. But the FDA can shut you down even if you didn’t make a single mistake - if you obstruct the inspection.

Here’s what counts as obstruction:

• Refusing to let inspectors enter certain areas
• Delaying access to records for hours
• Redacting parts of documents they asked for
• Turning off cameras or lights during inspection
• Limiting who can speak to inspectors

These aren’t just "bad manners." They’re violations of the Federal Food, Drug, and Cosmetic Act. And under Section 306 of FSMA, if a foreign facility refuses inspection, the FDA can automatically block all its products from entering the U.S. - no hearing, no appeal. That’s a death sentence for any exporter.

Even worse: obstruction can lead to criminal charges. The U.S. Department of Justice can prosecute foreign companies in American courts. Fines, asset seizures, and even debarment from selling to the U.S. market are possible. That’s not theoretical. In 2023, a Chinese seafood processor was fined over $1.2 million for refusing to show inspection records and limiting FDA access to its cold storage area.

How Foreign Facilities Are Adapting

Many factories, especially in India, China, and Southeast Asia, are scrambling to adjust. The ones that survived the transition did three things:

1. They hired bilingual quality staff full-time. No more calling translators from home. Now, every facility has at least one person on-site who speaks English and understands FDA expectations.
2. They went digital. Paper records are dead. Cloud-based systems that store sanitation logs, training records, and test results - accessible 24/7 - are now mandatory. Some use platforms like SAP or specialized food safety software like FoodLogiQ or Safefood 360.
3. They run mock inspections every month. One company in Vietnam does surprise internal audits every 30 days. They bring in a former FDA inspector to simulate a real visit. No one knows when it’s coming. If they fail, they shut down production until the issue is fixed.

Small family-run operations are struggling. One owner in Thailand told an industry group: "We used to have two weeks to clean up. Now we have to be ready every day. It’s like having a guard at your door 24/7. It’s expensive. It’s exhausting. But we have no choice. If we lose the U.S. market, we lose everything."

What You Need to Do Right Now

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

• Verify your registration is current with FDA’s FURLS system. If it’s expired, you’re already in violation.
• Digitize all records. Make sure they’re searchable, backed up, and accessible without a login delay.
• Train your team. Every employee, from the cleaner to the plant manager, must know what to do if FDA shows up. No one should panic or hide anything.
• Run monthly mock inspections. Hire an independent auditor if you can’t do it yourself.
• Know your rights - and your limits. You can’t refuse access. You can’t delay. But you can ask for a copy of the inspection notice and record the visit with your own camera.

The bottom line? The FDA isn’t trying to scare you. They’re trying to make sure your food doesn’t make someone sick. If your facility is clean, honest, and transparent, you have nothing to fear. But if you’ve been cutting corners, waiting for the next warning - that time is over.

What’s Next for FDA Overseas Inspections

The FDA isn’t stopping here. They’re testing new tools:

• Third-party inspectors: Licensed auditors in countries like Brazil and Indonesia are being trained to conduct inspections under FDA supervision. This could speed things up.
• AI-powered risk scoring: New software analyzes shipment data, refusal history, and supplier networks to predict which facilities are most likely to be unsafe.
• Real-time data sharing: Some exporters are now required to send lab results and temperature logs directly to FDA systems as they happen.

The message is clear: The days of playing catch-up are gone. The FDA wants food safety built into every step - not just during inspections.