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. About 15% of everything Americans eat comes from overseas - from spices in India to seafood in Vietnam, baby food in China, and olive oil in Italy. And if you’re running a factory that sends food to the U.S., you’re now under a much stricter microscope. Starting in 2024, the FDA stopped giving foreign facilities advance notice of inspections. No more warning calls. No more time to clean up, rearrange, or hire translators. If you’re not ready at 8 a.m. on a Tuesday, you’re in violation.

Why the FDA Changed the Rules

For years, American food plants were inspected without warning. Inspectors showed up unannounced, walked through the facility, checked records, and took photos - all without giving the company a heads-up. Meanwhile, foreign factories got weeks of notice. They could schedule the inspection for a slow day, clean the floors, train staff on scripted answers, and even arrange for interpreters. The FDA called it a "double standard." And in May 2024, they ended it.

The goal? To make sure every facility - whether in Ohio or Osaka - follows the same rules. If a plant in the U.S. can’t hide problems because inspections are random, then neither can a plant in Bangladesh. The FDA’s new policy says: if you want to sell food in America, you must be ready to show compliance at any moment, day or night, no excuses.

What Gets Inspected and How

The FDA doesn’t inspect every single foreign facility. There are over 300,000 registered food plants outside the U.S. That’s too many for 1,200 inspectors to cover. So they use a risk-based system. Three things decide who gets picked:

• What you make - High-risk foods like sprouts, shellfish, or infant formula get priority. Low-risk items like canned beans get less attention.
• How you make it - Processes with more steps, chemicals, or temperature controls are riskier. A facility that pasteurizes milk gets more scrutiny than one that just repackages nuts.
• Your record - If your products were denied entry into the U.S. before, you’re on the list. Repeat offenders get flagged fast.

The inspection itself looks at everything: sanitation, worker hygiene, equipment maintenance, recordkeeping, and how you handle allergens. Inspectors can walk anywhere, take photos, review digital files, and ask to see raw data from your quality control systems. They’re allowed to take samples on-site. And they don’t need your permission.

The Legal Power Behind the Inspection

The FDA doesn’t just ask for access. They can demand it - and punish you if you refuse. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the agency has legal authority to enter any facility producing food for U.S. consumption. If you block them, delay them, or hide records, you’re breaking U.S. law.

Here’s what counts as a violation:

• Refusing entry to an inspector
• Delaying the inspection by claiming "the manager is in a meeting"
• Redacting parts of documents or deleting digital files
• Turning off cameras or shutting down production during inspection
• Limiting where inspectors can go - like saying "you can’t go in the warehouse"

These aren’t just fines. The U.S. Department of Justice can bring criminal charges. Foreign companies have been prosecuted in U.S. courts for obstructing inspections. Penalties include fines, asset seizures, and being banned from exporting to the U.S. ever again.

What Foreign Facilities Must Do Now

You can’t prepare for an inspection anymore. So you have to be ready all the time. That means changing how you run your business.

• Keep records digital and always accessible - Paper files in a locked cabinet won’t cut it. Your HACCP plans, cleaning logs, and test results must be available instantly - even on weekends.
• Hire bilingual staff permanently - No more calling a translator when you hear the FDA is coming. Someone on your team must be fluent in English and trained to answer questions about your processes.
• Run weekly mock inspections - Pretend an inspector just walked in. Can your team produce records in 10 minutes? Can they explain how you control pathogens in your production line? If not, fix it.
• Don’t rely on contractors - If your quality control is outsourced, the FDA will still hold you responsible. You need direct control over your systems.

The FDA also won’t accept travel help from you anymore. No more offering hotel rooms, rides, or meals. Inspectors pay for their own lodging and transport. This isn’t about being rude - it’s about avoiding any appearance of favoritism.

Who’s Struggling - and Why

Small factories, family-owned businesses, and those in countries with weak food safety infrastructure are feeling the squeeze. A plant in Thailand that exports coconut milk might have a great product but no IT system to store digital records. A factory in Pakistan might have trained staff who speak only Urdu. These aren’t excuses under U.S. law - but they’re real challenges.

Some companies are adapting. Larger exporters - like Nestlé or Danone - have global compliance teams and digital platforms that sync data across countries. Smaller players? Many are dropping the U.S. market entirely. Others are hiring U.S.-based consultants to help them get ready.

The FDA admits the system isn’t perfect. With 300,000 facilities and only 1,200 inspectors, they can’t cover everyone. But they’re using data smarter. They’re tracking shipment denials, lab test results, and even social media complaints to find the worst offenders.

What Happens If You Get Inspected

If an FDA inspector shows up and finds problems, you’ll get a Form 483 - a list of observations. It’s not a fine. It’s a warning. You have 15 days to respond with a plan to fix it. If you ignore it, or if they come back and find the same issues, you’ll get a Warning Letter. After that, your products can be blocked at the border.

The worst-case scenario? Your facility gets placed on Import Alert. That means every shipment from your plant gets automatically detained. You have to prove each batch is safe before it’s allowed in. That can cost you millions in delays and lost sales.

The Bigger Picture

This isn’t just about food. It’s about trust. American consumers expect their food to be safe - no matter where it’s made. The FDA is trying to prove it can enforce that standard globally. Other countries are watching. The European Union, Canada, and Australia are considering similar unannounced inspection models.

For foreign manufacturers, the message is clear: if you want access to the U.S. market, you have to play by American rules - no exceptions. The days of treating U.S. inspections like a scheduled audit are over. Now, every day is inspection day.