Import Inspections: How the FDA Monitors Drugs Entering the U.S.

The U.S. Food and Drug Administration (FDA) doesn’t just check drugs made in America-it inspects every pill, vial, and capsule that crosses the border. With over 186 billion in pharmaceuticals imported annually, the FDA’s import inspection system is the last line of defense against unsafe, counterfeit, or poorly made drugs entering American homes. This isn’t just paperwork. It’s a high-stakes, real-time operation that stops tainted medications before they reach pharmacies and hospitals.

How the FDA Knows What’s Coming In

Every drug shipment entering the U.S. must be declared electronically through the FDA’s Prior Notice System Interface (PNSI). Importers-whether it’s a giant like Johnson & Johnson or a small biotech lab shipping research samples-must submit detailed information before the product even arrives. This includes the product type, manufacturer, country of origin, quantity, and intended use. The system flags anything unusual: a shipment from a facility with a history of violations, a product with missing labeling, or a quantity that doesn’t match the declared purpose.

The FDA reviews about 1.2 million entries each year. But here’s the key: 98% of those are screened automatically using risk-based algorithms. The system doesn’t look at everything the same way. A shipment of insulin from a German facility with a clean record gets low priority. A shipment of generic blood pressure pills from a factory in India with past compliance issues? That one gets flagged immediately.

The Five Steps of an FDA Import Inspection

There’s a clear process every shipment goes through:

1. Entry Submission: The importer files all required documents electronically.
2. Entry Review: The FDA’s system analyzes the data. If red flags appear, the shipment is held for further review.
3. Examination and Sampling: FDA inspectors physically check the product. This can mean verifying labels, checking storage conditions, or taking samples to test in a lab.
4. Compliance Review: Inspectors compare the product to U.S. standards: Is it manufactured under cGMP? Is it properly labeled? Is it registered with the FDA?
5. Final Admissibility Decision: The shipment is either released, held for corrections, or refused entry.

In 2022, about 14.3% of drug shipments that were physically examined were detained. Of those detained, nearly 68% were ultimately refused. That’s over 10,000 shipments blocked in a single year-many containing contaminated or mislabeled drugs.

What Gets You Detained

The FDA doesn’t detain shipments randomly. It’s based on clear violations:

• Adulterated drugs: Contaminated with harmful substances (like the 2022 valsartan case with NDMA, a cancer-causing chemical).
• Misbranded drugs: Missing required labeling, false claims, or incorrect dosage instructions.
• Unregistered facilities: If the manufacturing site isn’t listed with the FDA, the product is automatically held.
• Unapproved drugs: Any drug not cleared through an NDA, ANDA, or BLA.

One of the most common issues? Labeling errors. A simple typo in the strength or expiration date can trigger a detention. Another big one: incorrect product codes. According to CBP data, 28% of delays happen because the importer used the wrong Harmonized System (HS) code.

The Secure Supply Chain Pilot Program (SSCPP)

Not all importers are treated the same. The FDA runs the Secure Supply Chain Pilot Program, which lets top-tier manufacturers skip most inspections. To qualify, a company must:

• Have zero compliance violations for at least three years
• Pass a rigorous on-site audit by FDA inspectors
• Only import up to five designated products

As of late 2023, only 27 companies qualified. Johnson & Johnson, Pfizer, and a few other large players are in. For them, clearance time dropped from 7-10 days to under 48 hours. That’s a game-changer for just-in-time manufacturing.

But here’s the catch: the program is designed for big players. Smaller companies, especially generic drug makers, can’t meet the bar. Teva Pharmaceuticals reported that 37% of their API shipments from certain Indian facilities were detained in early 2023-even though their internal quality controls were flawless. The system isn’t broken. It’s just uneven.

The Big Change: No More De Minimis Exemptions

Until October 2023, shipments under $800 were exempt from FDA review. That loophole let people ship dangerous substances through the mail: fake Adderall, unregulated weight-loss pills, even pill presses. The FDA called it a public health risk. So they shut it down.

Now, every drug shipment-no matter how small or cheap-is subject to inspection. That’s added over 350,000 new entries to the FDA’s workload. It’s meant to stop the flood of counterfeit drugs. The Partnership for Safe Medicines estimates that $4.3 billion in fake medications entered the U.S. in 2022, mostly through those small packages.

The downside? Academic researchers and small biotech firms are feeling the pinch. One Reddit user reported that importing a biological sample for a lab study now costs $420 extra and takes 5 extra days. Medical schools are seeing delays in critical research. The Association of American Medical Colleges estimates costs for researchers have gone up by 22-35%.

Why Some Ports Are Worse Than Others

The FDA doesn’t have inspectors at every port. So where you ship matters. In 2022, the Port of Los Angeles detained only 5.2% of drug shipments. The Port of Miami? 18.7%. Why? It’s not random. Miami sees more shipments from Latin America and the Caribbean, where manufacturing oversight is weaker. Los Angeles handles more shipments from Europe and Canada, where regulatory standards are closer to the U.S.

Customs brokers say processing times are unpredictable. One broker told me they’ve seen the same shipment cleared in 2 days in New York and held for 11 days in Atlanta. The FDA says it’s due to staffing and case complexity. Importers say it’s lack of transparency.

What Importers Need to Get It Right

If you’re shipping drugs into the U.S., here’s what you can’t afford to mess up:

• Accurate product coding: Use the right HS code. A wrong code delays everything.
• Complete registration: Both the product and the facility must be registered with the FDA.
• Proper labeling: English labels, correct strength, expiration date, lot number, and manufacturer info.
• Documentation: Commercial invoice, bill of lading, and Affirmation of Compliance (A of C) must match exactly.

Even one typo can cost you over 4 days in delays. And if you get flagged once? You might get put on an Import Alert. That means every future shipment gets automatically detained until you prove you’ve fixed the problem.

The Future: AI, Blockchain, and Global Alignment

The FDA is upgrading. By 2025, they plan to use AI to improve risk scoring by 25%. They’re testing blockchain to track drug movement from factory to pharmacy. And they’re working with international regulators through PIC/S to align standards.

The goal? Faster clearance for safe products. Slower, more focused inspections for risky ones. But the system still has gaps. The Government Accountability Office found that only 4 out of 17 key performance metrics from the 2012 FDASIA law have been fully implemented.

The U.S. imports 88% of its active pharmaceutical ingredients. That’s not going away. The challenge isn’t stopping imports-it’s making sure the ones that come in are safe. The FDA’s system is the most advanced in the world, according to the WHO. But it’s stretched thin. And as e-commerce drug sales grow (41% of websites selling to U.S. customers operate outside FDA oversight), the pressure will only increase.

What This Means for You

If you’re a patient: You can trust that the FDA is watching. Most drugs are safe. But if you buy pills online from a site that doesn’t look professional, skip it. The FDA can’t catch everything.

If you’re a pharmacy or hospital: Work with suppliers who use the SSCPP. Ask if their manufacturers are FDA-registered and have clean inspection records.

If you’re an importer: Don’t guess. Use the FDA’s Electronic Entry Interface Repository. Talk to port reviewers. Build relationships. And never, ever cut corners on labeling or documentation. One mistake can shut down your entire supply chain.

The system isn’t perfect. But it’s the best we have. And right now, it’s the only thing standing between you and a dangerous drug that slipped through the cracks.