FDA Warning Authority: Actions Against Non-Compliant Manufacturers

The U.S. Food and Drug Administration (FDA) doesn’t just set rules - it enforces them. And when manufacturers cross the line, the FDA doesn’t wait. In 2025, the agency issued over 800 formal warning letters targeting companies that made, sold, or distributed products without meeting basic safety and quality standards. These aren’t gentle reminders. They’re legal notices that can lead to seized shipments, criminal charges, or even the permanent removal of a product from the market.

What Is an FDA Warning Letter?

An FDA Warning Letter is the agency’s most common formal step to stop unsafe or illegal products from reaching consumers. It’s not a suggestion. It’s a documented alert that a company has violated federal law under the Federal Food, Drug, and Cosmetic Act (FDCA). The letter lists every specific problem - from dirty equipment to false marketing claims - and gives the company 15 business days to respond with a plan to fix it.

These letters are issued by top officials, not mid-level inspectors. Since early 2023, under Commissioner Robert Califf, the FDA has returned to a 1990s-style enforcement model: more letters, faster action, and higher stakes. Warning Letters now carry the signature of the Director of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), not junior staff. That shift means the agency is treating these as serious regulatory actions, not paperwork.

How the FDA Catches Violations

The FDA doesn’t guess. It inspects. Every year, thousands of facilities - from drug factories in India to food plants in Iowa - get visited by FDA inspectors. During these unannounced checks, inspectors document problems on FDA Form 483. This isn’t a final decision. It’s a snapshot of what went wrong on-site.

If the issues are serious enough, the FDA follows up with a Warning Letter. Common violations include:

• Failure to follow Current Good Manufacturing Practices (cGMP)
• False or misleading claims about a product’s benefits
• Using unapproved ingredients or untested processes
• Refusing access during inspections
• Marketing unapproved drugs - especially compounded versions of popular medications like semaglutide

For example, in the first half of 2025 alone, the FDA issued 58 Warning Letters to telehealth companies and compounding pharmacies that were selling compounded GLP-1 drugs as if they were FDA-approved. These weren’t just minor labeling errors. These companies were advertising weight-loss drugs with claims that mimicked FDA-approved brands, putting patients at risk.

What Happens After a Warning Letter?

Receiving a Warning Letter isn’t the end - but ignoring it is. Companies have 15 business days to reply. That reply must include:

1. A clear list of steps taken to fix each violation
2. Deadlines for completing each fix
3. Proof that systems are now in place to prevent future problems

If the FDA finds the response inadequate, things get worse fast. The agency can:

• Issue a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) - this can bar a facility from supplying products to the U.S. market
• Issue an Import Alert - meaning every future shipment from that company gets automatically detained at the border
• Start a recall - either voluntary or mandatory
• Seek Civil Monetary Penalties - up to $1 million per violation
• Push for criminal prosecution - especially if a company delays or hides records during an inspection

One company in 2024 was fined over $2 million after ignoring a Warning Letter about contamination in its insulin manufacturing line. The FDA found that the firm had known about the issue for months but didn’t tell regulators or recall the product. That’s how serious this gets.

Targeted Enforcement: Food, Drugs, and Tobacco

The FDA doesn’t treat all industries the same. Enforcement priorities vary by product type.

Food Manufacturers

In 2024, the FDA issued 149 Warning Letters to human food facilities and 37 to animal food facilities. Most of these were for failing to follow the Food Safety Modernization Act (FSMA) rules - especially around Preventive Controls. This means companies didn’t properly assess risks like cross-contamination, allergen mixing, or improper storage. One facility in Texas was cited for storing raw chicken next to ready-to-eat meals. The FDA didn’t just warn them - they issued an Import Alert that blocked all future shipments.

Pharmaceuticals and Compounding

Compounding pharmacies that turn prescription drugs into custom doses are under heavy scrutiny. In 2025, over half of all FDA Warning Letters to drugmakers targeted companies selling compounded versions of GLP-1 drugs - like semaglutide - with claims that sounded just like Ozempic or Mounjaro. These companies weren’t licensed to make these products. They weren’t tested for safety. But they were marketing them aggressively online. The FDA’s response? A wave of letters and a public list of companies to avoid.

Tobacco Products

The FDA has issued more than 700 Warning Letters since 2021 targeting unauthorized vaping products and flavored tobacco. Many of these were sold in convenience stores or online with packaging that appealed to teens. The agency is now using AI tools to scan social media for illegal ads. One company in California was shut down after the FDA found its e-cigarette ads targeted high school students using TikTok influencers. The company’s owner now faces criminal charges.

What You Need to Do If You’re a Manufacturer

If your company makes drugs, food, or medical devices for sale in the U.S., here’s what you must do:

• Train your team on cGMP and FSMA rules - every year
• Keep detailed records of every batch, test, and inspection
• Never assume FDA won’t show up - unannounced inspections are now the norm
• Don’t respond to a Warning Letter with excuses. Respond with action
• Get legal counsel familiar with FDA enforcement - don’t rely on general lawyers

Companies that treat Warning Letters as a bureaucratic nuisance often end up in court. Those that treat them as emergencies - assembling a team of quality control, legal, and compliance staff within 24 hours - usually avoid bigger penalties.

What’s Next for FDA Enforcement?

The FDA’s 2026 budget includes $50 million to hire more inspectors and expand unannounced checks on foreign facilities. The agency plans to increase these inspections by 300% over the next two years. That means more companies overseas - especially in China, India, and Mexico - will be under the microscope.

Also, the FDA is now monitoring online ads and social media more closely. If your website or Instagram post makes a health claim that isn’t approved, you’ll get a letter - even if you’re a small business. The agency is using automated tools to scan for keywords like “miracle cure,” “FDA-approved alternative,” or “better than Ozempic.”

Expect more criminal referrals too. In 2025, the FDA referred 17 cases to the Department of Justice for criminal investigation - up from just 4 in 2022. Delaying inspections or shredding records can now lead to jail time.

Bottom Line

The FDA isn’t bluffing. Warning Letters are no longer just paperwork. They’re the first step in a legal process that can shut down your business, seize your inventory, and put your leadership in legal jeopardy. If you’re manufacturing anything for the U.S. market, compliance isn’t optional. It’s your lifeline.

Read every letter carefully. Fix every issue. Document everything. And never ignore a notice from the FDA - because they’re watching, and they’re ready to act.