Import Inspections: How the FDA Monitors Drugs Entering the US

Every year, over 100 million drug shipments enter the United States. Most come from overseas manufacturers in countries like India, China, Germany, and Switzerland. But how does the FDA make sure these drugs are safe, effective, and not counterfeit? The answer isn’t just random checks-it’s a complex, data-driven system designed to catch dangerous products before they reach pharmacies, hospitals, or your medicine cabinet.

How the FDA Reviews Every Drug Import

The FDA doesn’t inspect every single shipment. That’s impossible. Instead, it uses a risk-based system that screens nearly every entry electronically. About 98% of drug imports are reviewed by computer systems before they even reach a U.S. port. These systems look at the product type, manufacturer history, country of origin, past violations, and even the importer’s track record. If something looks off-a company with a history of violations, a shipment from a facility on the FDA’s watchlist, or a product labeled incorrectly-it gets flagged for further review.

Ships that pass the initial screen move forward. Those flagged? They’re held. The FDA then decides whether to examine the product physically, take samples for lab testing, or detain the entire shipment. In 2022, about 15.7% of drug entries were flagged for extra review. Of those, 14.3% of the ones physically examined were detained. And nearly 70% of those detained shipments were eventually refused entry.

The Five Steps of an FDA Import Inspection

The process isn’t random. It follows five clear steps:

1. Entry Submission - The importer or customs broker files electronic paperwork through the FDA’s system. This includes the product name, manufacturer, quantity, and proof that the facility is registered with the FDA.
2. Entry Review - The FDA’s automated system analyzes the submission. If it’s flagged, the shipment is put on hold.
3. Examination and Sampling - FDA inspectors may check the physical packaging, verify labels match FDA requirements, or take 1-3 units from the shipment for lab testing. They look for signs of tampering, incorrect ingredients, or contamination.
4. Compliance Review - If the product fails inspection-say, it’s not from a registered facility, lacks proper labeling, or contains banned substances-it’s marked as non-compliant.
5. Final Admissibility Decision - The FDA either lets the shipment in, requests corrections, or refuses entry. If refused, the importer can appeal, re-export, or destroy the product.

What Gets the FDA’s Attention?

Not all drugs are treated the same. The FDA focuses on high-risk products:

• Generic drugs from countries with poor inspection histories
• Active pharmaceutical ingredients (APIs) - the actual medicine in pills - which are often made overseas
• Products with suspicious labels, like fake brand names or missing lot numbers
• Shipment from facilities previously cited for violations

In 2022, 67.8% of detained drug shipments were refused because they violated current good manufacturing practices (cGMPs). That means the manufacturing process didn’t meet basic safety standards. Other common reasons: unregistered facilities, misbranded labels, or undeclared ingredients.

The De Minimis Loophole Is Gone

For years, small shipments under $800 - called “de minimis” - were exempt from FDA review. That meant anyone could mail pills from overseas without inspection. In 2023, the FDA closed that loophole. Now, even a single pill sent from India or China must go through the same review as a full container.

This change was made after reports of dangerous products slipping through: counterfeit cancer drugs, fake weight-loss pills laced with steroids, and even pill presses shipped in small packages. The Government Accountability Office found that before this change, $4.3 billion in counterfeit drugs entered the U.S. in 2022 alone. About 63% of those came through de minimis shipments.

The move has made things harder for researchers and small biotech firms. Importing biological samples for labs now costs $285-$420 more per shipment and adds 3-5 days to processing time. But the FDA says the trade-off is worth it. The system now catches more dangerous products before they reach patients.

Fast-Track for Trusted Companies: The SSCPP

Not all manufacturers are treated like suspects. The FDA runs a program called the Secure Supply Chain Pilot Program (SSCPP). Companies that have proven they follow strict quality controls for at least three years can get their products cleared in 24-48 hours instead of 7-10 days.

As of late 2023, only 27 companies qualified. They include big names like Johnson & Johnson. Their Global Regulatory Affairs Director said the program cut their clearance time variability from ±5 days to ±8 hours. That’s huge for just-in-time manufacturing.

But the program is hard to get into. Smaller companies, especially generic drug makers, struggle to meet the requirements. Teva Pharmaceuticals reported that 37% of their API shipments from certain Indian facilities were detained in early 2023-even though they were fully compliant. The system isn’t perfect. It’s catching bad actors, but sometimes good ones get caught in the net.

Why Some Shipments Still Slip Through

Despite all the technology, the FDA only physically inspects about 1.2% of the 100 million+ drug shipments that enter the U.S. each year. That’s not because they’re lazy-it’s because they can’t do more with current staffing and budgets.

That’s why they rely on risk models. But those models aren’t flawless. In 2022, a contaminated blood pressure medication called valsartan slipped in through a shipment that wasn’t flagged. The problem? The API came from a factory that had never been inspected before. The risk model didn’t flag it because it had no history.

The Government Accountability Office pointed out that only 4 of 17 key performance indicators required by law have been fully implemented. In other words, the FDA knows what it should be measuring, but it hasn’t built the systems to track them all.

What Importers Need to Get It Right

If you’re importing drugs into the U.S., here’s what you need to avoid delays:

• Register your facility - Every foreign manufacturer must be registered with the FDA. No exceptions.
• Use correct product codes - 28% of delays come from wrong or missing product codes.
• Match labels to FDA rules - Labels must include the manufacturer’s name, lot number, expiration date, and proper warnings. 19% of rejections are label-related.
• File complete paperwork - Missing bills of lading, commercial invoices, or Affirmations of Compliance can delay shipments by nearly 5 business days.
• Keep records for 3 years - FDA can audit you anytime. If you can’t prove compliance, you could get an Import Alert, which means every future shipment gets automatically detained.

Experienced importers say building a relationship with FDA reviewers at specific ports helps. One survey found that companies with direct contact saw processing times drop by 22-35%.

The Bigger Picture: Global Supply Chains

The U.S. imports 88% of its active pharmaceutical ingredients. That’s not going to change. The FDA knows it can’t inspect every shipment. So it’s investing in new tools: AI to predict which shipments are risky, blockchain to track drugs from factory to pharmacy, and partnerships with international regulators to share inspection data.

By 2025, the FDA plans to improve its targeting accuracy by 25%. They’re also expanding the SSCPP to include contract manufacturers, which could help smaller companies get faster clearance.

But the real challenge? Online pharmacies. Over 41% of websites selling drugs to U.S. customers operate outside any regulatory system. The FDA can’t shut them all down. So they focus on the big imports-the ones that feed pharmacies and hospitals.

What’s Next?

The system is evolving. More automation. Better data sharing. Tighter rules. But the core idea stays the same: protect public health without blocking legitimate trade.

For manufacturers, the message is clear: if you want your drugs into the U.S. quickly, you need to prove you’re trustworthy. For consumers, the system isn’t perfect-but it’s better than it was. And it’s getting smarter every year.