Unannounced FDA Inspections: Why Surprise Visits Are Critical for Drug and Food Safety

The U.S. Food and Drug Administration doesn’t call ahead. No warning. No email. No scheduled meeting. One day, you’re running your facility like normal-workers on the floor, machines humming, records stacked neatly-and the next, two FDA inspectors are standing at your door with badges and Form FDA 482 in hand. This isn’t a drill. It’s an unannounced FDA inspection, and it’s now the standard for every facility making drugs, medical devices, or food sold in the United States-no matter where in the world it’s located.

Why Surprise Visits Exist

The FDA doesn’t do unannounced inspections just to catch people off guard. It does them because preparation hides problems. When a company knows an inspection is coming, they clean up. They fix the obvious issues. They pull out the best records. They put the right people in the right places. But that’s not reality. Reality is what happens on a Tuesday at 10:17 a.m. when no one’s watching. That’s what the FDA wants to see.

Before May 2025, this was only true for U.S.-based factories. Foreign manufacturers-especially those in India, China, and other major supply hubs-got advance notice. Sometimes weeks. That created a double standard. A facility in Ohio might be inspected without warning and found with major violations. Meanwhile, a factory in Bangalore, with the same products and same standards, had time to fix everything before the inspectors arrived. And guess what? The FDA found serious problems more than twice as often in foreign facilities that got advance notice.

The May 2025 policy change ended that. Now, every facility-domestic or international-gets the same treatment: no notice. The goal is simple: protect American consumers by seeing what’s really happening, not what’s being staged.

How an Unannounced Inspection Actually Works

It starts with a knock. FDA investigators show up, identify themselves, and hand over Form FDA 482. That’s the official notice of inspection. They don’t ask for permission. They don’t wait for a manager to finish a meeting. They start immediately.

The inspection isn’t a tour. It’s a deep dive. They’ll ask for:

• Standard Operating Procedures (SOPs) for every step of production
• Manufacturing records from the last six months
• Deviation logs and corrective action reports
• Training records for every employee involved in quality control
• Equipment maintenance logs
• Raw material testing results

They might walk into your sterile cleanroom without warning. They might pull a batch from the shelf and ask for its full history. They might interview a line worker who’s never met a compliance officer before. If the records don’t match what’s happening on the floor, they write it down. That’s a Form 483-a list of observations that can lead to warning letters, import alerts, or even product recalls.

The inspection can last hours or days. It depends on how complex your operation is, how many issues they find, and how quickly you can produce documents. There’s no time limit. If they’re not satisfied, they stay.

The Big Shift: Foreign Facilities Are Now Targeted

About 80% of the active ingredients in U.S. medicines come from overseas. Nearly 40% of finished drugs are made abroad. Before May 2025, the FDA inspected about 3,000 foreign facilities each year-but most got advance notice. That meant inspectors were often seeing a cleaned-up version of reality.

The new policy changes everything. Now, the same surprise inspections that happen in Michigan or California also happen in Mumbai, Shanghai, and Mexico City. The FDA’s Office of Inspection and Investigations ran a pilot program in India and China for years. The results were clear: when facilities didn’t know inspectors were coming, violations were more visible, and compliance was more honest.

This isn’t just about fairness. It’s about safety. A facility that falsifies records or hides contamination won’t get caught if they have time to fix it. But if the inspectors show up without warning? The truth comes out.

The FDA now says this is a “new era in enforcement.” And they’re serious. They have the legal right to deny, delay, or limit an inspection-and they will take action against any company that tries.

What Happens If You’re Not Ready

Being unprepared isn’t an excuse. It’s a liability.

Many companies think they’re fine because they’ve passed announced inspections before. But that’s like thinking you’re a good driver because you passed your DMV test. The real test is driving in rush hour with no warning.

If your records are messy, your SOPs are outdated, or your staff doesn’t know what to do when an inspector walks in-you’re at risk. The FDA doesn’t care if you’re a small supplier or a global giant. They care about whether your product is safe.

A single Form 483 can block your product from entering the U.S. A pattern of violations can lead to an import alert-meaning every future shipment gets held at the border until you prove you’ve fixed everything. That’s expensive. That’s disruptive. That’s dangerous for your business.

How to Get Ready-Without a Warning

You can’t wait for the knock. You have to be ready every day.

Here’s what top-performing facilities do:

• Run mock inspections monthly. Have someone play FDA inspector. Surprise your team. See where the gaps are.
• Keep records digital and searchable. Paper files get lost. Digital systems with audit trails don’t. Use QMS software that auto-logs changes, tracks approvals, and flags deviations.
• Train everyone-not just managers. Line workers, warehouse staff, janitors-they all need to know what to do if an inspector shows up. Who to call. Where to find documents. What not to say.
• Designate a response team. One person handles the inspector. One handles records. One handles IT. One handles HR. No confusion. No delays.
• Review your SOPs quarterly. If your procedures haven’t changed in two years, they’re probably outdated. Update them. Document the changes. Train on them.

The FDA doesn’t expect perfection. They expect honesty and consistency. If your system works every day-not just when someone’s watching-you’ll pass.

What’s Next? The Unanswered Questions

The policy shift is clear. But some details aren’t.

For years, the FDA coordinated foreign inspections with local health authorities. They’d notify the Indian or Chinese food safety agency before arriving. Sometimes, those agencies even joined the inspection. Now? No one knows if that’s still happening.

There’s also the issue of language. If an inspector walks into a factory in Vietnam and no one speaks English, how do they communicate? The FDA hasn’t said whether they’ll bring translators or require facilities to have them on standby.

Industry experts are watching closely. These are not minor details. They’re operational hurdles that could slow down inspections-or create legal gray areas.

But the direction is unmistakable: the FDA is going global, and it’s going hard.

Bottom Line: Compliance Isn’t Optional

Unannounced inspections aren’t punishment. They’re protection. For consumers. For honest manufacturers. For the integrity of the entire supply chain.

If you’re making something that ends up in a U.S. pharmacy, grocery store, or hospital-you’re under the FDA’s watch. And now, that watch is always on.

The best defense? Stop thinking about inspections as events to prepare for. Start thinking about them as a daily standard. Because when the door opens, you won’t have time to fix anything. You’ll only have time to show what you’ve already built.