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

The U.S. Food and Drug Administration (FDA) doesn’t wait for dangerous drugs to reach pharmacy shelves before acting. Instead, it stops them at the border-sometimes before they even land. Since 1995, the FDA has used Import Alerts as its most powerful tool to block shipments from manufacturers with a history of violating quality standards. These aren’t random checks. They’re automated, data-driven detentions that can wipe out entire shipments in minutes. And in 2025, the system got a major upgrade-with the most aggressive enforcement ever seen in the pharmaceutical industry.

How Import Alerts Work: No Inspection Needed

Most people think customs inspections mean physical checks of every box. That’s not how FDA Import Alerts work. Once a manufacturer is flagged, every future shipment from that facility is automatically detained without physical examination-known as DWPE (Detention Without Physical Examination). This isn’t a guess. It’s based on hard data: past violations, inspection history, refusal rates, and even the type of drug being imported.

The system runs on PREDICT, an algorithm that evaluates over 150 data points. If a factory in India shipped a batch of semaglutide with impurities above safe limits last year, and another batch had missing documentation this spring, PREDICT flags the entire facility. The next shipment? Automatically held at the port. No waiting. No paperwork review. Just a system-wide block.

There’s no appeal at the dock. The importer must submit a full corrective action plan before the FDA even considers releasing the goods. That means Certificates of Analysis (CoA), third-party audit reports, facility compliance records, and proof that raw materials trace back to approved suppliers-all verified by FDA-recognized auditors.

The Green List: A New Era of Control

In September 2025, the FDA launched something unprecedented: the Green List. This isn’t just a blacklist. It’s a whitelist. Manufacturers who pass a rigorous compliance review get placed on the Green List. Their shipments clear automatically-99.2% of them, according to Customs and Border Protection data.

But if you’re not on the Green List? You’re in the red zone. For GLP-1 active pharmaceutical ingredients (APIs) like semaglutide, tirzepatide, and liraglutide, refusal rates hit 98.7% in October 2025. That’s not a mistake. It’s policy.

The move targeted a market worth $35.2 billion in 2024. Compounded and illegally imported GLP-1 weight-loss drugs had flooded the U.S. through gray-market channels. Many were contaminated. Others had incorrect dosing. Some didn’t even contain the claimed ingredient. The FDA’s Director of Pharmaceutical Quality, Dr. Susan Huang, called it a public health emergency. The Green List was the response.

Who Gets Blocked-and Why

The data doesn’t lie. Of the 89 manufacturers caught in the September 2025 GLP-1 Import Alert, 73 were in India. Nine were in China. Seven were in Europe. The rest were scattered across 12 other countries.

But it’s not just about geography. It’s about systems. A facility might have ISO 9001 certification, but if their auditor isn’t FDA-recognized, the shipment gets refused. One manufacturer on Reddit lost $1.2 million in 72 hours-not because their drug was unsafe, but because their audit report didn’t meet FDA’s exact formatting rules.

Common reasons for refusal:

• Incorrect or incomplete Certificate of Analysis (41.7% of cases)
• Missing facility master production records (33.8%)
• Unverified traceability of raw materials (28.5%)
• Failure to prove stability under required conditions (2-8°C, 25°C, 40°C)

The FDA doesn’t care if you’re a big name or a small lab. If your paperwork doesn’t match their standards, your product gets held. And if you’ve been flagged before? You’re on the Yellow or Red List-and you’re not getting another chance without a full compliance overhaul.

The Cost of Non-Compliance

Getting caught isn’t just a delay. It’s financial ruin.

Refused shipments must be exported or destroyed within 90 days. If you don’t comply, Customs and Border Protection can hit you with liquidated damages-up to three times the value of the goods. For a $900,000 shipment, that’s $2.7 million in penalties. Frier Levitt attorneys documented this in October 2025, and it’s not theoretical. Companies are already paying it.

Some are trying to game the system. ProPublica found at least 157 products received exemptions since 2013, including items from companies with repeated violations. Meanwhile, regulatory forums report brokers are being paid to falsify export documents so companies can avoid destruction fees. The FDA issued Warning Letter 541598 in October 2025 to a Singapore-based intermediary for exactly this.

The financial impact is massive. Viatris reported a $417 million revenue hit in Q3 2025. Generic manufacturers are scrambling. Meanwhile, Novo Nordisk’s partners gained nearly 19% market share in six weeks. The import alert didn’t just block bad drugs-it reshaped the entire supply chain.

How to Get Back On the Green List

Getting removed from an Import Alert isn’t easy. The average time? 11.7 months. Some take over two years.

The FDA requires four steps:

1. A full facility inspection (minimum 5 days)
2. A root cause analysis with a detailed Corrective and Preventive Action (CAPA) plan
3. Three consecutive compliant shipments verified by the FDA
4. Executive certification signed by a company officer

Most petitions fail the first time. Only 42.1% of document-only submissions get approved. But companies that include video evidence of their fixes? Approval jumps to 87.4%. One company showed footage of their new quality control lab, their staff training, and their updated batch tracking system. They got approved in 5 months.

Now, many are investing in blockchain traceability. Pfizer spent millions integrating the MediLedger network across 17 API suppliers. Their Green List acceptance rate? 99.8%. That’s not luck. That’s systems.

The Global Ripple Effect

This isn’t just an American issue. The FDA’s move is forcing global change.

The European Medicines Agency (EMA) is adopting similar API screening protocols by mid-2026. China’s National Medical Products Administration (NMPA) now requires all API exporters to meet FDA-equivalent facility certifications starting January 1, 2026. That’s a huge shift for a country that once dominated the global API market.

Indian manufacturers are in crisis. The Indian Pharmaceutical Alliance estimates 28,500 jobs are at risk. Prices for compounded GLP-1 drugs in the U.S. have jumped 14.3% since October. Pharmacy benefit managers are warning patients: the cheap, online versions are disappearing.

Meanwhile, big players are buying up capacity. Catalent’s $980 million acquisition of Novasep’s peptide business in October 2025 was directly tied to the new import rules. They’re not just expanding-they’re betting on compliance.

What’s Next?

The FDA isn’t stopping with GLP-1 drugs. In November 2025, Commissioner Dr. Robert Califf announced the same import alert framework will expand to all high-risk biologics starting in Q1 2026. Monoclonal antibodies are next.

The agency also launched the API Transparency Portal in November 2025, giving real-time status updates on 1,842 registered manufacturers. It’s a first. You can now see if your supplier is on the Green List-or if they’re about to be blocked.

But the system isn’t perfect. Critics argue it’s too harsh. Dr. Rachel Sherman, former FDA deputy commissioner, warns that automatic detentions could push consumers toward even riskier underground markets. Others say the Green List creates artificial scarcity and drives up prices.

Yet the data backs the FDA’s concerns. A September 2025 study found 68.4% of refused GLP-1 shipments contained impurities above international safety thresholds. The public health risk is real.

The message is clear: if you want to sell drugs in the U.S., you don’t just need good product-you need perfect paperwork, verified systems, and full transparency. The era of cutting corners is over. The border doesn’t just check for contraband anymore. It checks for compliance.