When you take a pill, use an inhaler, or eat packaged food, you assume it’s safe. But how do you know it really is? The answer lies in a quiet, unpredictable force: the unannounced FDA inspection. These surprise visits aren’t about catching companies off guard for the sake of it. They’re about finding the truth - the real, everyday state of a manufacturing facility - before something goes wrong.
Why surprise inspections matter
The U.S. Food and Drug Administration doesn’t call ahead. Not usually. That’s by design. If a factory knows inspectors are coming, they clean up. They fix what’s broken. They hide what’s not. But real life doesn’t pause for inspections. Real safety means checking how things run on a Tuesday morning in March, not on the day after someone gets a heads-up.
Before May 2025, this rule mostly applied to factories in the U.S. Foreign facilities - the ones making 80% of the active ingredients in American medicines - got weeks of notice. They arranged translators, pulled records, and rehearsed answers. Meanwhile, domestic plants faced random visits. That wasn’t fair. And it wasn’t safe.
The FDA saw the numbers: when foreign facilities were given advance notice, inspectors found serious problems more than twice as often as during unannounced visits to U.S. sites. That’s not a coincidence. It’s a system that rewarded deception.
The May 2025 shift: equal rules for everyone
On May 6, 2025, the FDA made a historic move. They extended unannounced inspections to all foreign manufacturing facilities that supply products to the U.S. No more warnings. No more prep time. If you make medicine, food, or medical devices for American consumers, you’re subject to the same rules as a plant in Ohio or California.
This wasn’t a small tweak. It was a full overhaul of global oversight. The FDA had been testing this in India and China for years. Now, it’s the rule everywhere. Around 3,000 foreign facilities are affected annually, across more than 90 countries. The goal? Regulatory parity. Same standards. Same surprise. Same accountability.
It also ties directly to President Trump’s May 5, 2025 executive order, which demanded stronger oversight of overseas manufacturing. The FDA didn’t just comply - they expanded it. They now say this marks “a new era in FDA enforcement - stronger, smarter, and unapologetically in support of the public health and safety of Americans.”
What happens during an unannounced visit
Imagine it: you’re running production. A knock on the door. Two people in suits show ID. One hands you Form FDA 482 - the official Notice of Inspection. No warning. No time to call your lawyer. You have to respond, right then.
The inspectors don’t come to chat. They come to look. They’ll ask for:
- Standard Operating Procedures (SOPs) - and proof they’re actually followed
- Manufacturing records - from batch logs to environmental monitoring
- Quality control data - including raw material testing and finished product results
- Facility maintenance logs - HVAC, water systems, cleaning schedules
- Employee training records - not just certificates, but proof of competency
They might walk into a sterile room mid-production. They might pull a random batch and demand the full chain of documentation. They don’t care if you’ve been “cleaning up.” They care if you’re always clean.
Inspections can last hours or days. It depends on the size of the facility, the complexity of the processes, and what they find. Even if they issue a “No Action Indicated,” that’s still valuable intel. It tells the FDA the facility is operating properly - and that’s a win for public safety.
Who gets inspected - and who doesn’t
Not every facility is treated the same. The FDA uses a risk-based system.
Class II and Class III medical devices usually get announced inspections every two years. But quality system inspections - the ones that check if your whole manufacturing process is built to last - are always unannounced. So are “for cause” inspections. That’s when the FDA gets a tip, sees a pattern of failures, or gets a complaint. No warning. Just show up.
Pharmaceutical manufacturers? Unannounced visits are the norm. Especially if you’re making injectables, sterile products, or high-risk generics. One Bioprocess International report described an inspector walking into a sterile manufacturing area mid-run. No notice. No pause. Just a question: “Can I see your environmental monitoring logs for the last 30 days?”
Food producers? Same deal. If you’re making baby formula, peanut butter, or packaged meals for the U.S. market, you’re on the list. The FDA doesn’t care if you’re in Bangalore or Baltimore. If it ends up on an American shelf, it’s fair game.
How companies prepare - because you can’t wait
You can’t prepare for a surprise. But you can prepare for the possibility of one.
Companies that survive these inspections don’t panic. They don’t scramble. They’ve built systems that work every day - not just on inspection day.
- Use a quality management system (QMS) that tracks everything automatically - not a spreadsheet that gets updated when someone remembers
- Train staff daily on SOPs - not once a year during orientation
- Run mock inspections every quarter - with no warning, just like the real thing
- Designate a response team: who answers the door? Who retrieves records? Who speaks to inspectors?
- Keep all documentation digital, searchable, and backed up - physical files can be lost, damaged, or “conveniently” missing
Greenlight Guru put it bluntly: “You won’t always have time to duct-tape your legacy system tools before they walk through your door.” That’s the truth. If your records are messy, your training is outdated, or your cleaning logs are fake - inspectors will find it. And they’ll write it down.
The FDA has the power to block shipments, shut down production, or even issue warning letters that make investors run. A single Form 483 observation can cost millions. So why gamble?
The global ripple effect
Before 2025, the FDA often coordinated with foreign regulators. They’d notify the local health authority, invite them to observe, and share inspection plans. That helped build trust. But under the new unannounced policy, that’s unclear.
Lawyers at Hogan Lovells are asking: Will the FDA still call ahead to foreign authorities? Or will they show up cold, like they do in the U.S.? The answer could change how global regulators work together - and whether foreign governments feel their sovereignty is being respected.
For now, the FDA hasn’t said. But companies can’t wait for clarity. They need to assume the worst: that inspectors will arrive without warning, without coordination, and without mercy.
The bottom line
Unannounced inspections aren’t punishment. They’re protection. They’re how the FDA makes sure that the medicine you rely on isn’t just labeled right - it’s made right.
For manufacturers, it’s not about fear. It’s about discipline. It’s about building a culture where compliance isn’t a checklist - it’s a habit. Because when the door knocks, you won’t have time to fix what’s broken. You’ll only have time to show what you’ve already built.
The FDA’s message is clear: if you want to sell to Americans, you play by American rules. No exceptions. No advance notice. Just truth.
Are all FDA inspections unannounced?
No. While most inspections are unannounced, there are exceptions. For example, the FDA sometimes gives advance notice to foreign facilities if they’re coordinating with local authorities, or for certain programs where records need to be prepared. Class II and Class III medical device manufacturers often receive scheduled visits every two years. But quality system inspections - the ones that check your entire manufacturing process - are always unannounced. So are inspections done "for cause," like after a complaint or a pattern of violations.
What happens if a company refuses an FDA inspection?
Refusing an FDA inspection is a serious violation. The FDA is legally authorized to take action against any facility that delays, denies, or limits access. This can include seizing products, issuing warning letters, or blocking imports. In extreme cases, the FDA can pursue criminal charges. Companies that resist inspections are seen as high-risk, and their products are likely to be flagged for future scrutiny or even banned from the U.S. market.
Do unannounced inspections only target foreign facilities?
No. Unannounced inspections have always been the standard for U.S.-based facilities. The big change in May 2025 was extending this practice to foreign manufacturers. Before that, foreign sites usually got weeks of notice. Now, both domestic and international facilities face surprise visits. The goal is to eliminate a double standard and ensure all products entering the U.S. meet the same safety standards.
How often do unannounced inspections happen?
There’s no fixed schedule. The FDA uses a risk-based approach. High-risk facilities - like those making sterile injectables or active pharmaceutical ingredients - are inspected more frequently. Low-risk facilities might go years without one. But since the May 2025 policy change, the FDA has signaled it will increase the frequency of unannounced inspections at foreign sites. The exact timing depends on inspection history, product type, and regulatory priorities.
What documents do FDA inspectors usually request?
Inspectors typically ask for Standard Operating Procedures (SOPs), manufacturing batch records, quality control test results, equipment maintenance logs, environmental monitoring data (especially for sterile areas), employee training records, and complaint handling logs. They want to see if procedures are documented, followed, and consistent - not just on paper, but in daily practice. Digital records that are time-stamped and auditable are far more valuable than handwritten logs.
