How the FDA Inspects Drugs Entering the U.S. to Ensure Safety and Quality

How the FDA Inspects Drugs Entering the U.S. to Ensure Safety and Quality

Every year, over 100 million shipments of drugs enter the United States. Most come from overseas manufacturers in countries like India, China, Germany, and Ireland. The FDA doesn’t physically check every single one. In fact, it inspects less than 1.2% of them. So how does it keep unsafe or fake drugs out of American medicine cabinets? The answer isn’t luck-it’s a complex, data-driven system built to catch problems before they reach patients.

Since 2023, there’s been a major shift: no more exceptions. Before, small shipments under $800-called "de minimis"-were exempt from FDA review. That loophole let dangerous pills, unapproved injectables, and even pill presses slip through. Now, every drug shipment, no matter how small, gets reviewed. It’s a big change, and it’s forced manufacturers, pharmacies, and researchers to adapt fast.

The Five-Step FDA Import Process

The FDA doesn’t just show up at the dock and start opening boxes. There’s a clear, five-phase process that every drug shipment must go through:

1. Entry Submission: The importer or customs broker files electronic paperwork through the FDA’s Prior Notice System Interface (PNSI). This includes details like the drug name, manufacturer, quantity, port of entry, and whether it’s an active ingredient or finished product.
2. Entry Review: The FDA’s automated system scans the submission in seconds. About 98% of entries are reviewed this way. If something looks off-missing documentation, a known bad manufacturer, or a product flagged in past inspections-the system flags it.
3. Examination and Sampling: If flagged, the shipment is held. FDA inspectors may do a physical check, examine the labels, or take samples to send to a lab. They don’t test every pill-they test a few from each batch. Those samples are checked for strength, purity, contamination, and whether the product matches its label.
4. Compliance Review: Inspectors compare the product against U.S. standards: Is it made in a registered facility? Does it follow current good manufacturing practices (cGMP)? Is the labeling accurate? If it fails any of these, it’s detained.
5. Final Admissibility Decision: The FDA decides: admit, refuse, or recondition. Refused shipments are either destroyed or returned. In 2022, 14.3% of physically inspected drug shipments were detained, and nearly 7 out of 10 of those were permanently refused.

This isn’t guesswork. The FDA uses real-time data from past inspections, global alerts, and even social media reports to target high-risk shipments. A shipment from a facility that previously shipped tainted valsartan? It’s flagged. A product with a label that doesn’t list all ingredients? It’s held.

Who Gets Checked-and Who Doesn’t

Not all drug imports are treated the same. The FDA uses risk-based targeting to focus its limited resources. Here’s how it breaks down:

• High-risk shipments: These make up about 15.7% of all reviewed entries. They include products from manufacturers with past violations, unregistered facilities, or those linked to counterfeit drug networks.
• Detention without Physical Examination (DWPE): If a company has a history of violations, the FDA can detain all future shipments from them without even opening the box. As of 2023, 12.1% of entries fall into this category.
• Low-risk shipments: These are cleared electronically within hours. Most come from trusted manufacturers with clean records.

But here’s the catch: the system isn’t perfect. In 2022, a batch of contaminated blood pressure medication slipped through because it came from a facility that had never been flagged before. The FDA didn’t have enough data to know it was risky. That’s why they’re building new tools.

The Secure Supply Chain Pilot Program (SSCPP)

Some companies don’t get inspected at all-because they’ve earned their way out of the line. The Secure Supply Chain Pilot Program lets top-tier manufacturers skip routine inspections if they meet strict standards.

To qualify, a company must:

• Have zero compliance violations for at least three years
• Pass a rigorous on-site audit by FDA inspectors
• Use traceable, secure supply chains for active ingredients
• Designate up to five products for expedited clearance

As of Q3 2023, only 27 companies qualified. Big names like Johnson & Johnson and Pfizer are in. But most small and generic drug makers aren’t. The program cuts clearance time from 7-10 days to under 48 hours. For companies that need just-in-time manufacturing, that’s a game-changer.

But it’s also controversial. Critics say it creates a two-tier system: big companies get fast lanes, while smaller ones face delays and higher costs. Teva Pharmaceuticals reported that 37% of its generic API shipments from certain Indian facilities were detained in early 2023-even though they were compliant. Why? Because the facility had a history of past issues, and the FDA still treats it as high-risk.

Why Some Shipments Get Held-and What Happens Next

Detention isn’t the end. It’s a pause. When a shipment is held, the importer gets a notice explaining why. Common reasons:

• Product isn’t registered with the FDA
• Labeling doesn’t match U.S. requirements (missing active ingredients, wrong dosage info)
• Facility isn’t registered or has been cited for cGMP violations
• Product contains unapproved ingredients or contaminants

Fixing these issues isn’t easy. If the label is wrong, you can’t just slap on a new sticker-you have to repackage the whole batch. If the facility isn’t registered, you’re stuck until the FDA approves it, which can take months. Many small importers don’t realize how strict these rules are until their shipment sits at the port for weeks.

And once a shipment is detained, the clock starts ticking. If the importer doesn’t respond within 90 days, the FDA automatically refuses the product. It’s then destroyed or returned at the importer’s expense.

Real-World Challenges for Importers

For big pharma, the system works. For smaller players, it’s a minefield.

Biotech startups that import research samples now face $285-$420 extra per shipment and delays of 3-5 days. Academic labs report research timelines stretched by weeks. One university in Boston had to cancel a clinical trial because a critical drug sample was held for 18 days over a missing form.

Customs brokers, who handle most of the paperwork, say the system is more transparent than before-but still unpredictable. In 2023, 58% of brokers reported more client complaints about delays. Why? Because the FDA doesn’t give exact timelines. One shipment clears in 24 hours. The next, from the same company, gets held for a week. There’s no public explanation.

Errors in documentation are the biggest cause of delays. A wrong product code? That’s 28% of problems. Missing registration numbers? 21%. Incorrect manufacturer name? 19%. One typo can cost thousands in storage fees and lost time.

What’s Changing in 2024 and Beyond

The FDA isn’t standing still. Its five-year plan includes:

• Expanding the SSCPP from 27 to 50 companies by mid-2024, including contract manufacturers
• Testing blockchain technology to track drugs from factory to pharmacy
• Rolling out AI tools to improve risk scoring by 25% by 2025
• Working with international regulators through PIC/S to align inspection standards

These changes aim to reduce delays for trustworthy companies while catching more bad actors. But they come at a cost. The Congressional Budget Office estimates the upgrades will cost $187 million over five years. And while the system is ranked second-best globally by the WHO, experts warn it’s still under-resourced. With 42.7% of U.S. drug supply coming from abroad, and 88% of active ingredients imported, the FDA is trying to police a global supply chain with a small team.

Meanwhile, the black market for fake drugs still thrives. The Partnership for Safe Medicines estimates $4.3 billion in counterfeit medications entered the U.S. in 2022-mostly before the de minimis rule change. Even now, 41% of websites selling drugs to Americans operate outside FDA oversight. The agency can’t shut them down if they’re based overseas.

What Importers Need to Do Now

If you’re importing drugs into the U.S., here’s what you must do:

1. Register your facility with the FDA. It’s free, but mandatory. If you don’t, your shipment will be detained.
2. Ensure your labeling meets 21 CFR Part 201. No missing ingredients, no false claims, no tiny print.
3. Use the PNSI system for electronic submissions. Paper forms are slow and error-prone.
4. Keep records for 3 years. The FDA can audit you anytime.
5. Build relationships with FDA reviewers at your port of entry. Importers who do this report 22-35% faster clearance times.

And if you’re a small company? Consider working with a customs broker who specializes in pharmaceuticals. The average cost is $285-$450 per entry, but it’s cheaper than losing a shipment-or getting an Import Alert that blocks all future shipments.

Final Thoughts: Safety, Not Perfection

The FDA’s import system isn’t flawless. It’s underfunded, complex, and sometimes inconsistent. But it’s the best we have. It’s stopped thousands of contaminated, mislabeled, and fake drugs from reaching patients. It’s also forced the global pharmaceutical industry to raise its standards.

The real challenge isn’t just catching bad products-it’s making the system fairer for everyone. Small companies need help navigating the rules. Big companies need to be held accountable. And the public needs to know: when you take a pill, the FDA didn’t just trust it. They checked it.