Import Alerts: How the FDA Blocks Drugs from Non-Compliant Manufacturers
Every year, the U.S. FDA stops over $1.8 billion worth of drugs at the border. Not because they’re fake, but because they’re made in factories that don’t meet basic safety standards. This isn’t random. It’s a system called Import Alerts-and it’s changing how the world makes medicine.
What Are FDA Import Alerts?
The FDA doesn’t inspect every drug shipment coming into the U.S. There are too many-12 million entry lines annually. Instead, they use a risk-based system that flags manufacturers with a history of problems. Once a facility is flagged, every future shipment gets automatically held at the port. No inspection needed. No paperwork review. Just detained. This is called Detention Without Physical Examination (DWPE). It sounds harsh, but it’s designed to stop bad products before they reach pharmacies, hospitals, or your medicine cabinet. The system started in 1995 but got a major upgrade in 2025 with the launch of the Green List initiative, focused squarely on GLP-1 weight-loss drugs like semaglutide and tirzepatide.The Green List, Yellow List, Red List
The FDA doesn’t just say “yes” or “no.” They use three color-coded lists to show where a manufacturer stands:- Green List: Facilities that passed strict audits and meet all quality standards. Their shipments clear customs in under 24 hours, with a 99.2% approval rate.
- Yellow List: Facilities with past issues but showing progress. Shipments may be held for review and require extra documentation.
- Red List: Facilities with repeated violations. Every shipment is automatically detained. No exceptions.
Why GLP-1 Drugs Are a Priority
GLP-1 drugs like Ozempic and Mounjaro are in huge demand. The global market hit $35.2 billion in 2024. But with demand outpacing supply, counterfeiters and unregulated manufacturers jumped in. Many of these companies cut corners: using untested raw materials, skipping stability tests, or falsifying Certificates of Analysis. FDA testing found that 68.4% of refused GLP-1 shipments contained impurities above safe limits set by the International Council for Harmonisation (ICH Q3D). Some had toxic solvents. Others had incorrect dosing-sometimes double or half what they claimed. One batch of tirzepatide API was found to contain a carcinogenic impurity at 12 times the allowed level. Dr. Susan Huang, head of the FDA’s Office of Pharmaceutical Quality, called it a public health emergency. “These aren’t just unapproved drugs,” she said in September 2025. “They’re dangerous.”What Happens When a Shipment Gets Blocked?
When a shipment is detained, the importer has 90 days to decide: export it or destroy it. No exceptions. No delays. And the penalties are steep. Under U.S. customs law (19 CFR § 159.14), companies can be fined up to three times the value of the shipment. For a $900,000 batch of API, that’s $2.7 million in penalties. That’s not a rumor-it’s happened. Frier Levitt attorneys documented a case in October 2025 where a Singapore-based intermediary paid over $2 million in liquidated damages after trying to re-route a refused shipment. But the real cost isn’t just fines. It’s lost time. Lost trust. Lost customers. One Indian manufacturer reported losing $1.2 million in 72 hours when their shipment was refused-even though they had ISO 9001 certification. Why? Because ISO doesn’t mean FDA-compliant. The auditor wasn’t FDA-recognized. The documentation didn’t match FDA format. The batch records weren’t traceable to Tier 3 suppliers.
The Real Roadblocks: Documentation, Not Just Quality
Here’s the surprising truth: most shipments get rejected not because the drug is bad-but because the paperwork is wrong. Registrar Corp’s analysis of 2025 refusals showed:- 41.7% failed because the Certificate of Analysis (CoA) was formatted incorrectly
- 33.8% lacked full facility master production records
- 28.5% couldn’t prove where their raw materials came from
How to Get Off the List (If You’re on It)
Getting removed from an Import Alert isn’t easy. It takes time, money, and patience. The FDA requires four steps:- A full, unannounced inspection at your facility (minimum 5 days)
- A root cause analysis with a detailed Corrective and Preventive Action (CAPA) plan
- Three consecutive shipments that pass inspection without issue
- A signed certification from your CEO or quality head
Who’s Being Hit the Hardest?
The GLP-1 import alert is reshaping the global drug supply chain. India, which once supplied over 60% of the world’s generic APIs, is now the biggest target. 73 of the 89 affected facilities are there. Many are small to mid-sized companies that never had the resources to meet U.S. standards. The Indian Pharmaceutical Alliance estimates 28,500 jobs are at risk. Some factories are shutting down. Others are selling out to bigger players. Catalent’s $980 million acquisition of Novasep’s peptide business in October 2025 wasn’t random-it was a direct response to the new rules. Meanwhile, U.S. pharmacies are seeing price hikes. Express Scripts reported a 14.3% increase in the cost of compounded GLP-1 formulations in November 2025. Insurance companies are pushing back. Patients are getting frustrated.
Is the System Fair?
Critics say yes-it’s necessary. Dr. Peter Lurie, former FDA official, called the Green List a “long-overdue fix” to the API oversight gap exposed by the 2023 semaglutide shortage. But others warn it’s too blunt. Dr. Rachel Sherman, former FDA deputy commissioner, said automatic detention risks pushing patients toward even riskier gray-market suppliers. “If you make legal drugs too expensive or hard to get,” she warned, “people will find illegal ones.” And there’s a loophole: exemptions. Since 2013, the FDA has granted 157 enforcement discretion exemptions. Mylan/Viatris got 14 exemptions for endoscopy equipment-even while their facilities had ongoing violations. Shilpa Medicare got seven exemptions for diabetes drugs in 2024 alone. That inconsistency is fueling legal challenges. Four Indian pharmaceutical associations filed a lawsuit in November 2025, arguing the Green List violates international trade rules.What’s Next?
The FDA isn’t stopping with GLP-1 drugs. In November 2025, Commissioner Dr. Robert Califf announced the system will expand to all high-risk biologics-starting with monoclonal antibodies in Q1 2026. That means insulin, cancer drugs, and autoimmune treatments could soon face the same scrutiny. China’s NMPA is already responding. Starting January 1, 2026, all API exporters to the U.S. must have FDA-equivalent facility certifications. The European Commission announced similar rules will take effect by mid-2026. The message is clear: if you want to sell drugs in the U.S., you need to meet U.S. standards. No shortcuts. No exceptions. No excuses.What This Means for You
If you’re a patient: your medicine is safer. The FDA is blocking dangerous products before they reach you. If you’re a pharmacist or provider: expect delays. Prices may rise. But the drugs you’re giving out will be more reliable. If you’re a manufacturer: the bar is higher. You need more than good intentions. You need documented proof. You need audits. You need traceability. You need to invest. The cost of compliance? $500,000 to $2 million per facility by 2027, according to McKinsey. But the cost of non-compliance? Millions in fines. Lost shipments. Reputational ruin. And possibly, lives lost. This isn’t about regulation for the sake of regulation. It’s about making sure the medicine you take doesn’t hurt you more than it helps.What is an FDA Import Alert?
An FDA Import Alert is a public notice that identifies specific manufacturers, products, or countries whose shipments are subject to automatic detention at U.S. ports without physical inspection. It’s triggered by repeated violations of U.S. drug quality standards, such as poor manufacturing practices, contamination, or falsified documentation.
How does the FDA decide which manufacturers to target?
The FDA uses its PREDICT risk algorithm, which analyzes over 150 data points: past inspection results, refusal rates, facility history, product type, and importer compliance. If a manufacturer has multiple violations, their future shipments get flagged automatically. It’s not random-it’s data-driven.
Can a company get removed from an Import Alert?
Yes, but it’s difficult. Companies must pass a full FDA inspection, submit a detailed corrective action plan, prove three consecutive compliant shipments, and get a signed certification from leadership. The average time to get removed is nearly a year. Video evidence of corrections improves approval chances dramatically.
What’s the Green List?
The Green List is a new FDA initiative launched in September 2025 to identify API manufacturers that meet the highest quality standards. Shipments from Green List facilities are cleared quickly-99.2% approval rate. It’s designed to reward compliance and give importers confidence in their supply chain.
Why are so many Indian manufacturers affected?
India produces over 40% of the world’s generic drugs, including many APIs for GLP-1 medications. Many smaller Indian manufacturers lacked the resources or oversight to meet U.S. standards. When the FDA ramped up enforcement on GLP-1 APIs in 2025, 73 of the 89 targeted facilities were in India-82% of the total.
Are there any exemptions to the import ban?
Yes. Since 2013, the FDA has granted 157 enforcement discretion exemptions-meaning certain shipments were allowed in despite being from flagged manufacturers. Examples include Mylan/Viatris’ endoscopy equipment and Shilpa Medicare’s diabetes drugs. These exemptions have raised concerns about fairness and consistency in enforcement.
What happens if a shipment is refused?
The importer has 90 days to either export the shipment out of the U.S. or destroy it under FDA supervision. Failure to act results in fines up to three times the shipment’s value. For a $900,000 drug batch, that could mean a $2.7 million penalty.
Will this affect my prescription medications?
If your medication is a brand-name drug from a U.S. or EU manufacturer, it’s unlikely to be affected. But if it’s a generic version-especially for GLP-1 drugs, insulin, or biologics-there could be delays or price increases as supply chains adjust. The FDA’s goal is to ensure safety, not to create shortages, but the transition period is causing market disruption.