FDA Foreign Facility Inspections: What Overseas Manufacturers Must Know in 2025

The U.S. Food and Drug Administration doesn’t just check factories in Ohio or California. Every day, it sends inspectors to food and drug plants in India, China, Mexico, Italy, and beyond. If your product ends up on a shelf in the U.S., it likely came from one of these foreign facilities-and the FDA is watching closer than ever.

Why Foreign Inspections Matter Now More Than Ever

About 15% of the food Americans eat comes from overseas. That’s more than $180 billion worth of products every year. Fresh produce, spices, seafood, supplements, and even baby formula often cross borders before hitting grocery stores. But here’s the problem: if a factory abroad cuts corners, the contamination doesn’t stop at the border. Outbreaks of salmonella, listeria, and undeclared allergens have all traced back to foreign facilities that didn’t follow U.S. standards.

The FDA Food Safety Modernization Act (FSMA), passed in 2011, changed everything. Instead of waiting for problems to happen, the FDA now has to prevent them. That means checking facilities before their products even get on a ship. But for years, there was a double standard. While U.S. plants got surprise visits, foreign ones got weeks of notice. They cleaned up, hired translators, hid issues-and inspections became more like guided tours than real checks.

That changed in May 2024. The FDA announced it would start doing unannounced inspections at foreign facilities-just like it does at home. No more warning calls. No more time to fix things before the inspector walks in. If you’re exporting to the U.S., you must be ready every single day.

How the FDA Picks Which Factories to Inspect

The FDA doesn’t have enough inspectors to visit all 300,000 registered foreign food facilities. So they don’t try. Instead, they use a risk-based system to pick targets.

Three things decide if your plant gets flagged:

• What you make - High-risk foods like raw sprouts, shellfish, or infant formula get top priority. Low-risk items like canned goods or baked snacks are lower on the list.
• How you make it - Complex processes with multiple steps, raw ingredients, or temperature-sensitive handling raise red flags. Simple packaging or bottling? Less concern.
• Your history - If your products got turned away at U.S. ports before, you’re now on the FDA’s watchlist. Refusals pile up fast.

The law also requires the FDA to double inspections every year for five years after FSMA passed. While progress slowed during budget cuts in the late 2010s, the agency has been pushing hard since 2022 to catch up. In 2024, inspections in India and China jumped by 40% compared to the previous year. That’s not a coincidence.

What Happens During an Unannounced Inspection

Imagine waking up to a knock on your factory door. No call. No email. Just two FDA inspectors in suits, asking to see your records and your production line.

They can inspect any part of your facility. That means:

• Walking through your mixing rooms, even if you’re in the middle of a batch.
• Reviewing your training logs, sanitation schedules, and equipment maintenance records.
• Taking photos of your equipment, storage areas, and even your trash bins.
• Interviewing your staff-no translators provided by you.

The FDA doesn’t accept help from your company anymore. No rides in your limo. No hotel rooms paid for by your team. Inspectors book their own flights, hotels, and meals. Why? To avoid any appearance of favoritism or influence.

If you try to hide something, you’re breaking the law. That’s not a warning. That’s a federal crime. You can’t:

• Delay the inspection
• Refuse to let them see a room
• Redact records
• Turn off cameras during inspection
• Block them from taking photos

The U.S. Department of Justice can prosecute foreign companies for obstruction. Fines can reach millions. Your facility can be banned from exporting to the U.S. forever. And your executives could be barred from working in the industry.

What Foreign Facilities Are Doing to Prepare

Companies that survived the transition to unannounced inspections didn’t just panic-they adapted.

One large supplement manufacturer in Bangalore started doing weekly internal mock inspections. They trained staff to treat every day like inspection day. They hired two full-time bilingual quality assurance officers. They moved all records to a cloud-based system that’s accessible 24/7-even from outside the country.

Another seafood processor in Vietnam installed digital logs that automatically timestamp every cleaning cycle, temperature reading, and employee shift. No paper. No gaps. No excuses.

The common thread? Constant readiness. No more “inspection week.” No more last-minute cleaning. You don’t prepare for the inspection-you live it.

What Happens If You Fail

A failed inspection doesn’t mean immediate shutdown. But it does mean trouble.

The FDA issues a Form 483 listing observations. This isn’t a fine-it’s a warning. If you fix the issues quickly, you might get another chance. But if you ignore it, or if the same problems show up again, the FDA can refuse entry of your products.

That’s called a “Detention Without Physical Examination.” Your shipment sits at the port. No testing. No appeal. Just stuck.

If you keep getting refused, the FDA can place you on an Import Alert. That means every future shipment gets automatically held. You have to prove you’ve fixed everything-sometimes with third-party audits-and wait weeks or months to get back on track.

Some companies have lost 60% of their U.S. sales overnight after being placed on an Import Alert. That’s not just a setback. It’s a business killer.

Who’s Getting Left Behind

Big companies with global teams and compliance departments are adapting fast. But smaller operations? They’re struggling.

A family-run spice mill in Thailand told a trade association they couldn’t afford a full-time quality manager. They used to get two weeks’ notice. Now they’re scared to answer the phone. They don’t know how to respond to an FDA inspector who walks in without warning.

Language barriers are real. One inspector asked for “the last three months of calibration records” and the plant manager handed over a handwritten notebook from 2021. The inspector didn’t speak Thai. The translator wasn’t there. The shipment got detained.

The FDA doesn’t make exceptions. They don’t care if you’re small. If you export to the U.S., you play by U.S. rules.

What’s Next for FDA Oversight

The FDA isn’t stopping here.

They’re testing AI tools to predict which facilities are most likely to fail based on past data, supplier history, and even weather patterns (yes, humidity affects mold growth in spices). They’re starting to use third-party auditors-approved and paid by the FDA-to do preliminary checks. These aren’t replacements, but they help prioritize who gets a full FDA visit.

They’re also pushing for digital submission of records. Soon, you may not be able to hand over paper logs. Everything will need to be uploaded in real time.

The goal? To make the U.S. the strictest, most reliable food safety system in the world. And if you want to sell here, you’ll need to meet that standard.

Bottom Line: Are You Ready?

If you’re a foreign manufacturer exporting to the U.S., here’s your checklist:

• Are your records digital, complete, and accessible 24/7?
• Do you have at least one bilingual staff member trained to handle FDA questions?
• Have you conducted at least five unannounced internal audits this year?
• Do you know what a Form 483 looks like-and how to respond to it?
• Have you trained your team to never delay, deny, or limit an inspection?

This isn’t about compliance. It’s about survival. The FDA isn’t going away. The rules aren’t getting easier. If you’re still treating inspections like a scheduled visit, you’re already behind.