Every year, over 12 million drug shipments enter the United States. Not all of them are safe. In fact, the FDA blocks hundreds of thousands of them - not by inspecting each one, but by targeting entire factories before they even ship. This isn’t guesswork. It’s a system built on data, history, and hard rules. And since September 2025, it’s become much sharper - especially for weight-loss drugs like semaglutide and tirzepatide.
What Are FDA Import Alerts?
An FDA Import Alert is a public notice that says: stop this shipment. It doesn’t mean the product is definitely dangerous. It means the factory, or the importer, has a pattern of violations. Maybe they’ve shipped contaminated batches before. Maybe their quality control documents are fake. Maybe they’ve ignored warnings for years. Once a facility lands on an Import Alert list, every future shipment from them gets automatically held at U.S. ports - no inspection needed.
This system started in 1995, but it got a major upgrade in 2025 with the PREDICT program. PREDICT uses over 150 data points to score risk: past inspection results, refusal rates, facility location, even the type of drug being made. If a factory has a history of failed inspections or shipments that got rejected at customs, PREDICT flags it. Then, Customs and Border Protection (CBP) blocks it before it clears U.S. soil.
The Green, Yellow, and Red Lists
Not all manufacturers are treated the same. The FDA uses a color-coded system:
- Green List: These manufacturers have proven compliance. Their shipments clear customs within hours. Over 99% of Green List shipments are released without delay.
- Yellow List: These facilities have minor or recent issues. Shipments may be held for review, but not automatically detained.
- Red List: These are the worst offenders. Every shipment gets automatically refused. No exceptions. No second chances.
As of November 2025, there were 238 active Import Alerts across all drug types. But the biggest change came in September 2025 with Import Alert 66-80 - targeting GLP-1 active pharmaceutical ingredients (APIs). This alert specifically named semaglutide, tirzepatide, liraglutide, and other weight-loss drug ingredients. The FDA didn’t just block shipments. They created the Green List to reward compliant makers and punish the rest.
Why GLP-1 Drugs? The Public Health Crisis
GLP-1 drugs exploded in popularity. Demand surged. But manufacturing couldn’t keep up. So, unapproved versions flooded in - often from factories in India and China with poor oversight. The FDA found contamination, incorrect dosing, and fake certificates. One lab found 68.4% of refused GLP-1 shipments had impurities exceeding safety limits. Another found 22.1% of blocked shipments actually met chemical standards - but failed because the paperwork was missing or forged.
Dr. Susan Huang, director of the FDA’s Office of Pharmaceutical Quality, said it plainly: “The proliferation of unapproved GLP-1 products poses significant public health risks.” Patients weren’t just getting subpar drugs. They were getting dangerous ones. Some batches had heavy metals. Others had wrong concentrations - too little to work, too much to be safe.
Who Gets Hit the Hardest?
The numbers don’t lie. Of the 89 facilities affected by the GLP-1 Import Alert, 73 are in India. Nine are in China. Seven are in Europe. That’s not random. It’s because India is the world’s largest supplier of generic APIs - and many of its factories cut corners to meet demand.
One manufacturer in Hyderabad lost $1.2 million in 72 hours when their shipment was refused. They had ISO 9001 certification - but the FDA doesn’t recognize it. Only FDA-recognized third-party audits count. They didn’t have the right Certificate of Analysis format. No facility master records. No traceability back to raw material suppliers. One missing document. One shipment. One million-dollar loss.
And it’s not just small players. Big companies like Viatris reported a $417 million revenue hit in Q3 2025. Meanwhile, Novo Nordisk’s approved partners gained 18.7% market share in just six weeks. The playing field got cleaned up - fast.
What Happens to Blocked Shipments?
If a shipment gets detained, the clock starts ticking. The importer has 90 days to either:
- Export it back out of the U.S., or
- Destroy it under FDA supervision.
Fail to act? The FDA can seize the goods. And they can charge liquidated damages - up to three times the value of the shipment. A $900,000 shipment could cost over $2.7 million in penalties. That’s not a fine. That’s a business-ending blow.
Some companies are gaming the system. ProPublica found cases where intermediaries paid brokers to falsify export documents - pretending the drugs left the U.S. when they never did. The FDA caught one Singaporean firm in October 2025 and issued a Warning Letter. This isn’t just about quality. It’s about trust.
How to Get Off the List - If You’re on It
Getting off an Import Alert isn’t easy. It takes months. The FDA requires four steps:
- A full facility inspection (minimum 5 days).
- A root cause analysis with a detailed corrective action plan (CAPA).
- Three consecutive shipments that pass inspection.
- Executive certification signed by the company’s top quality officer.
Most companies fail the first time. The FDA’s own data shows it takes 2.3 extra submissions on average. The most successful petitions? Those that include video proof - footage of cleaned labs, trained staff, updated systems. Companies that submitted video had an 87.4% approval rate. Those with only paperwork? 42.1%.
And now, the FDA is making it a little easier. Since November 12, 2025, facilities with FDA-recognized auditors can get onto the Green List in 45 days - half the time it used to take. But the cost? A single audit can run $45,000 to $68,000. Add in stability testing across three temperature zones, supply chain mapping, and blockchain traceability systems - and you’re looking at $200,000 to $500,000 in upgrades.
What’s Next? The Global Ripple Effect
The U.S. isn’t alone anymore. In November 2025, the European Medicines Agency announced it would adopt a similar API screening system by mid-2026. China’s NMPA is now requiring all API exporters to meet FDA-equivalent standards starting January 1, 2026. The global supply chain is being rewired.
Big players are adapting. Catalent bought Novasep’s peptide business for $980 million - specifically to control more of the GLP-1 API supply. Pfizer, after deploying the MediLedger blockchain across 17 suppliers, now has a 99.8% Green List acceptance rate. Smaller manufacturers? They’re struggling. The Indian Pharmaceutical Alliance estimates 28,500 jobs are at risk. U.S. pharmacies are seeing 14.3% price hikes on compounded GLP-1 drugs.
And the FDA isn’t stopping. Commissioner Dr. Robert Califf said in November 2025 that the GLP-1 alert framework will expand to all high-risk biologics - starting with monoclonal antibodies in Q1 2026. That means more factories. More alerts. More pressure.
The Bottom Line
This isn’t about bureaucracy. It’s about safety. The FDA isn’t trying to hurt businesses. It’s trying to stop poisoned drugs from reaching patients. The system isn’t perfect. False positives happen. Small companies get crushed. But the alternative - letting uncontrolled, untested drugs into the U.S. supply - is worse.
If you’re a manufacturer, the message is clear: compliance isn’t optional. Documentation isn’t paperwork. It’s your license to sell. If you’re a patient, know this: the drug you’re taking came from a factory that passed a thousand checks. That’s not luck. That’s enforcement.
The next time you hear about a drug shortage, don’t blame supply chains. Blame the factories that cut corners - and the system that finally caught them.
What triggers an FDA Import Alert?
An FDA Import Alert is triggered when there’s a pattern of violations from a specific manufacturer or importer. This includes repeated shipment refusals, failed inspections, falsified documentation, contamination findings, or failure to correct previous warnings. The PREDICT system analyzes over 150 data points, including facility history, product risk level, and importer compliance records, to determine if automatic detention is warranted.
Can a company get removed from an Import Alert?
Yes, but it’s difficult. Companies must complete a full facility inspection, submit a detailed corrective action plan (CAPA), prove three consecutive compliant shipments, and get executive certification. The process typically takes 11.7 months on average. Submitting video evidence of improvements increases approval chances from 42% to over 87%.
Why are Indian manufacturers hit hardest by the GLP-1 Import Alert?
India produces over 60% of the world’s generic APIs, and many factories rushed to meet soaring demand for GLP-1 drugs like semaglutide. In the rush, quality controls slipped - leading to contamination, documentation errors, and unverified supply chains. Of the 89 facilities affected by Import Alert 66-80, 73 (82%) are in India. The FDA’s system targets repeat offenders, and many Indian facilities had prior violations.
What documents are required to avoid shipment detention?
To avoid detention, importers must provide: a Certificate of Analysis (CoA) that meets FDA format standards, facility master production records, batch-level traceability to Tier 3 suppliers, and proof of third-party audit by an FDA-recognized body. Missing or improperly formatted documents - not necessarily product quality - are the most common cause of refusal.
What happens to drugs that are refused entry?
Refused shipments must be exported from the U.S. or destroyed under FDA supervision within 90 days. Failure to act can lead to seizure of goods and liquidated damages up to three times the commercial value of the shipment. For a $900,000 shipment, penalties could exceed $2.7 million.
Is the Green List fair, or does it favor big companies?
The Green List is technically neutral - any facility can apply. But the cost and complexity of compliance ($500,000-$2 million in upgrades) make it harder for small manufacturers to compete. While large firms like Pfizer and Novo Nordisk can afford blockchain traceability and FDA-recognized audits, smaller players often lack resources. Critics argue this creates market consolidation, while the FDA says it’s necessary to protect public health.
Will other countries adopt the FDA’s Import Alert system?
Yes. The European Medicines Agency announced in November 2025 it will adopt similar API screening protocols by Q2 2026. China’s NMPA now requires FDA-equivalent facility certifications for all API exporters starting January 1, 2026. The U.S. system is becoming the global benchmark for drug import safety.
The FDA’s system isn’t perfect, but it’s the only thing standing between me and a counterfeit semaglutide pen that could’ve killed me. I’ve seen what happens when people buy online ‘generic’ versions - hospital visits, kidney damage, the whole mess. This isn’t bureaucracy. It’s damage control.
And yes, it’s brutal on small manufacturers, but if your ‘quality control’ is a Google Doc and a prayer, you shouldn’t be making drugs for Americans. The Green List exists because people died waiting for regulators to catch up.