Import Alerts: How the FDA Blocks Drugs from Non-Compliant Manufacturers

The U.S. Food and Drug Administration doesn’t wait for unsafe drugs to reach pharmacy shelves. It stops them at the border - and it’s getting more aggressive than ever. Since September 2025, the FDA has been using a powerful tool called Import Alerts to block shipments of active pharmaceutical ingredients (APIs) from manufacturers with a history of violations. This isn’t about random inspections. It’s about automatic detention. If your facility isn’t on the Green List, your drugs won’t clear customs. Period.

How Import Alerts Work: The Green, Yellow, and Red System

The FDA’s Import Alert system isn’t new, but its recent expansion makes it feel like a game-changer. Under the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) program, the agency tracks over 150 data points: inspection history, past shipment refusals, facility compliance records, and even the type of drug being imported. Based on that data, manufacturers are placed on one of three lists:

Green List: Manufacturers with proven, documented compliance. Their shipments are cleared automatically - 99.2% of the time.
Yellow List: Facilities with past issues but showing improvement. Shipments are held for review and may require extra documentation.
Red List: Facilities with repeated violations. Shipments are detained without physical examination (DWPE). No inspection needed. No second chance.

This system replaced the old approach of randomly checking 10-15% of shipments. Now, if you’re on the Red List, your entire shipment gets blocked the moment it hits a U.S. port. The FDA doesn’t need to open a single box. The algorithm does it for them.

The GLP-1 Crackdown: Why Semaglutide and Tirzepatide Are Targeted

The biggest shift came in September 2025, when the FDA issued Import Alert 66-80, targeting GLP-1 receptor agonists - the active ingredients in weight-loss drugs like semaglutide (Ozempic, Wegovy) and tirzepatide (Zepbound). Why? Because the market exploded, and so did the risks.

With demand outpacing supply, unapproved, untested, and often contaminated versions flooded the U.S. market. Some were mixed with toxic impurities. Others had doses 50% higher or lower than labeled. The FDA’s own data showed 68.4% of refused GLP-1 shipments contained impurities beyond international safety limits (ICH Q3D). That’s not a mistake - that’s a public health threat.

The agency responded with the “Green List” initiative. Only manufacturers who passed FDA-recognized third-party audits, submitted full stability testing data, and proved end-to-end supply chain control got on the list. The result? Shipments from non-Green List facilities are now being refused at a 98.7% rate. In just one month, over $1.84 billion worth of GLP-1 APIs were blocked at U.S. ports.

Who’s Getting Hit the Hardest?

The crackdown isn’t random. It’s focused. According to FDA enforcement reports from October 2025, 73 of the 89 affected facilities (82%) are in India. Nine are in China. Seven are in Europe. Why India? Because it’s the world’s largest supplier of generic APIs - and a major source of GLP-1 ingredients.

But it’s not just about geography. It’s about compliance. Many Indian manufacturers had ISO 9001 certification, which sounds solid - until you realize ISO doesn’t require FDA-specific documentation. One manufacturer on the FDA Compliance subreddit lost $1.2 million in 72 hours because their auditor wasn’t FDA-recognized. That’s not a technicality. It’s a deal-breaker.

The same goes for documentation. The most common reasons for refusal? Incomplete Certificates of Analysis (41.7%), missing master production records (33.8%), and no traceability back to raw material suppliers (28.5%). It’s not that the drugs are bad. It’s that the paperwork doesn’t prove they’re safe.

Pharmaceutical engineer examining a contaminated tablet with glowing impurities, surrounded by failing compliance metrics.

The Cost of Getting It Wrong

Getting caught on the Red List isn’t just inconvenient - it’s financially devastating. Once a shipment is detained, the importer has 90 days to either export it or destroy it under FDA and Customs and Border Protection (CBP) supervision. If they fail to act, penalties kick in.

Under 19 CFR § 159.14, liquidated damages can reach up to three times the commercial value of the goods. For a $900,000 shipment, that’s $2.7 million in fines. That’s not theoretical. Frier Levitt attorneys documented a case where a single shipment cost a company over $2 million in penalties and lost revenue.

And it doesn’t stop there. Companies are now paying brokers to falsify export paperwork just to avoid destruction costs. The FDA issued Warning Letter 541598 in October 2025 to a Singaporean intermediary caught doing exactly that. The system is forcing some to choose between losing millions or breaking the law.

What It Takes to Get on the Green List

Getting off the Red List or onto the Green List isn’t a quick fix. It’s a 11.7-month average process - and that’s if you do everything right.

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 without issue.
An executive certification signed by a company officer.

But even that’s not enough. Companies that submit video evidence of their corrections have an 87.4% approval rate. Those who only send documents? Just 42.1%. The FDA wants to see proof - not paper.

The cost? $45,000 to $68,000 for a single FDA-recognized audit. Another $200,000 to $500,000 to install blockchain traceability systems that track every batch from raw material to finished product. Pfizer did it with the MediLedger network across 17 suppliers - and now their API shipments clear at 99.8% approval.

FDA inspector standing before a glowing blockchain traceability wall, with a container being destroyed in the background.

What This Means for the Global Drug Supply

The impact is rippling through the entire pharmaceutical industry. The GLP-1 market was worth $35.2 billion in 2024. Now, with 92.4% of non-Green List API imports blocked, prices for compounded versions have jumped 14.3% in November 2025 alone. Pharmacy benefit managers are scrambling to find alternatives.

Manufacturers are consolidating fast. Catalent bought Novasep’s peptide business for $980 million in October 2025 - explicitly to secure compliant supply chains. Viatris reported a $417 million revenue hit in Q3 2025. Meanwhile, 28,500 jobs in India are at risk.

Even global regulators are reacting. The European Commission announced in November 2025 that the EMA will adopt a similar API screening system by mid-2026. China’s NMPA will require FDA-equivalent certifications for all API exports starting January 1, 2026. The U.S. isn’t just setting the standard - it’s forcing the world to follow.

The Big Question: Is This Fair?

Critics say the system is too harsh. Dr. Rachel Sherman, former FDA deputy commissioner, warns that automatic detentions could push patients toward even riskier gray-market suppliers. Others point out that 22.1% of refused shipments met pharmacopeial standards but failed paperwork - meaning the problem isn’t always safety, it’s bureaucracy.

There’s also the issue of exemptions. Since 2013, the FDA has granted 157 enforcement discretion waivers - including to Mylan/Viatris, despite ongoing violations at their facilities. That inconsistency fuels distrust.

But the data backs the FDA’s urgency. Impurities. Mislabeling. Lack of traceability. These aren’t hypotheticals. They’re documented dangers. And with biologics like monoclonal antibodies next on the list (set to be added in Q1 2026), the message is clear: compliance isn’t optional. It’s the price of doing business with the U.S. market.

What Manufacturers Need to Do Now

If you’re a supplier, distributor, or importer of APIs:

Check if your facility is on the FDA’s Import Alert list - and which color you’re on.
Don’t assume ISO 9001 or GMP certification is enough. You need FDA-recognized audits.
Start documenting every step of your supply chain - down to Tier 3 raw material sources.
Invest in blockchain traceability. It’s not a luxury anymore. It’s a requirement.
Prepare for a 12-month remediation timeline if you’re off the Green List.

The window for easy compliance is closed. The new standard is transparency, verification, and accountability. If you’re not ready, your drugs won’t make it past the border - and your business won’t survive the fallout.

What is an FDA Import Alert?

An FDA Import Alert is a public notice that authorizes customs officials to automatically detain shipments of drugs or ingredients from specific manufacturers or countries without needing to physically inspect them. These alerts are issued when the FDA sees a pattern of violations, such as poor manufacturing practices, contamination, or falsified documentation. Once an alert is active, shipments from listed sources are held at U.S. ports until the importer proves compliance.

How do I know if my facility is on the Green, Yellow, or Red List?

You can check the FDA’s official Import Alert page, which lists all active alerts and the manufacturers involved. The Green List is published separately under the GLP-1 Import Alert 66-80. If your facility isn’t listed, you’re likely on the Red or Yellow List - meaning your shipments are at risk of detention. You can also contact the FDA’s Office of Pharmaceutical Quality directly for clarification.

Can I appeal an Import Alert decision?

Yes, but it’s not easy. You must submit a formal petition to the FDA with full documentation: a detailed root cause analysis, a corrective action plan (CAPA), evidence of three consecutive compliant shipments, and an executive certification. Video proof of facility improvements increases your approval chances by over 45%. The average petition takes 11.7 months to resolve - and many companies need multiple submissions before approval.

What happens if my shipment is detained?

Your shipment will be held at the port of entry. You have 90 days to either export it out of the U.S. or destroy it under FDA supervision. If you don’t act, the FDA can seize the goods and impose penalties up to three times the shipment’s value. For example, a $900,000 shipment could lead to $2.7 million in fines. Many companies pay brokers to falsify export records to avoid destruction - but that’s illegal and can lead to criminal charges.

Why are so many Indian manufacturers affected?

India produces over 40% of the world’s generic APIs, including most of the GLP-1 ingredients used in weight-loss drugs. Many Indian facilities exported large volumes without full FDA compliance documentation. The FDA’s recent crackdown exposed gaps in traceability, testing, and auditing. Of the 89 facilities targeted under Import Alert 66-80, 73 (82%) are in India. It’s not a ban on India - it’s a demand for proof of quality.

Will this affect my prescription medications?

For FDA-approved brand-name drugs, no - those supply chains are tightly controlled. But for compounded versions of GLP-1 drugs or unapproved generics, yes. Prices have already risen 14.3% in November 2025 due to supply shortages. If your medication relies on imported APIs from non-compliant manufacturers, you may face delays, higher costs, or even unavailability. The FDA’s goal is to ensure safety, not to restrict access - but the transition is causing short-term disruption.