Foreign Manufacturing of Generics: How the FDA Oversees Drug Quality Abroad

More than 80% of the active ingredients in your generic medications come from factories in India and China. Yet until recently, the U.S. Food and Drug Administration inspected those foreign plants far less often-and with far less surprise-than those in the United States. That double standard is ending. In May 2025, the FDA announced a sweeping shift: at least half of all foreign inspections will now be unannounced. This isn’t just bureaucratic housekeeping. It’s a direct response to rising risks to public health, and it’s changing how hundreds of drugmakers around the world operate.

Why Foreign Manufacturing Matters

The U.S. doesn’t make most of its generic drugs anymore. About 90% of all generic prescriptions filled in America rely on medicines produced overseas. India supplies nearly 40% of the active pharmaceutical ingredients (APIs), while China contributes another 13%. Finished pills, injections, and capsules come from factories in dozens of countries. This global supply chain keeps prices low, but it also creates blind spots.

For decades, the FDA treated foreign and domestic facilities differently. Domestic plants got surprise inspections-no notice, no warning. Foreign plants? They often got 8 to 12 weeks’ notice. That’s enough time to clean up, polish records, hide problems, or even temporarily shut down troubled lines. It’s not that the rules were different. The Current Good Manufacturing Practices (CGMP) standards apply equally to every facility, whether it’s in Ohio or Odisha. But the enforcement? That was uneven.

What the FDA Actually Checks

FDA inspectors don’t just walk in and look around. They dig into the details. They check training logs to see if workers were properly taught to avoid contamination. They review equipment maintenance records. They trace how samples are tested and whether results were altered. They look at how the facility handles water quality, air filtration, and waste disposal-all critical for preventing harmful particles from getting into pills.

During an inspection, they use Form 483 to list any issues they find. These aren’t minor complaints. They’re violations of federal law. Common findings at foreign plants include:

• Missing or falsified lab data
• Inadequate cleaning between batches
• Using expired or unapproved ingredients
• Failure to investigate why a batch failed quality tests

In 2024, foreign inspections found these kinds of problems more than twice as often as domestic ones. Nearly half of all foreign inspections uncovered serious quality control failures. Data integrity issues-like changing test results or deleting records-showed up in 38.7% of foreign inspections. At U.S. plants, that number was just 17.2%.

The Big Change: Unannounced Inspections

On May 6, 2025, FDA Commissioner Marty Makary made it clear: the old system was broken. “We can’t wait for companies to clean up before we show up,” he said. “We need to see what’s really happening.”

The new policy requires foreign facilities to be ready for inspectors at any moment. No more advance notice. No more “inspection prep days.” The FDA plans to increase unannounced inspections from about 15% of total foreign visits to at least 50% by mid-2026. That means factories in Hyderabad, Shanghai, and Bangalore now have to keep their quality systems running perfectly every single day-not just when they think someone’s coming.

The impact is immediate. Companies that used to rely on last-minute fixes are scrambling. A survey by the Parenteral Drug Association found 68% of foreign manufacturers expect compliance costs to rise 15-25%. Smaller plants, especially, are struggling to afford the upgrades needed for real-time documentation, automated testing, and 24/7 quality monitoring.

What Happens When a Factory Fails

Failing an inspection doesn’t mean a plant is shut down overnight. But it does trigger consequences. The FDA can issue a warning letter. It can block imports from that facility. In extreme cases, it can ban all products from entering the U.S. market.

One notorious example: Sun Pharma’s facility in India. The FDA banned it from exporting drugs in 2021 after finding serious contamination and data falsification. Yet, four drugs from that same facility were still allowed into the U.S. for months afterward. ProPublica’s investigation found that internal FDA reviews had flagged the risks-but enforcement actions were delayed or overridden.

That’s why Congress is pushing for change. In April 2025, Senators Kirsten Gillibrand and Tim Scott demanded a full review of FDA’s enforcement decisions, citing cases where safety concerns were ignored to avoid drug shortages. They also raised alarms about potential ties between some foreign manufacturers and forced labor in China-a human rights issue that’s now part of the regulatory conversation.

What Foreign Manufacturers Need to Do Now

If you’re a drugmaker in India, China, or elsewhere supplying the U.S. market, here’s what you need to do:

• Conduct daily quality system audits
• Run mock inspections every quarter with no warning
• Train every employee on proper documentation-no exceptions
• Fix contamination control gaps immediately
• Keep real-time digital records that can’t be altered

Experts say it takes 6 to 9 months to fully adapt. The learning curve is steep. Many companies are hiring consultants to help them prepare. Others are investing in automated systems that log every step of production, from raw material intake to final packaging.

The Generic Pharmaceutical Association reports that 42% of its members with foreign facilities have already added new quality checks since the May 2025 announcement. That’s a sign the industry is waking up.

Could the U.S. Copy the EU’s System?

The European Union doesn’t just inspect factories. It requires every drug batch to be certified by a “Qualified Person” (QP)-a trained professional who physically signs off before the product leaves the plant. That person is legally responsible. If something goes wrong, they’re on the hook.

Brookings Institution researchers argue the U.S. should adopt a similar model. Instead of relying on foreign manufacturers to police themselves, the U.S. could require importers to designate a U.S.-based QP who verifies each shipment meets CGMP standards. That would add a layer of accountability right at the border.

It’s not a perfect fix. But it’s a step beyond inspections alone. The FDA’s Foreign Supplier Verification Program (FSVP), which already works for food, could be expanded to drugs. Right now, it’s not.

What This Means for You

You take generic medications because they’re affordable. You assume they’re safe. That assumption is now being tested-and strengthened.

The FDA’s new approach doesn’t guarantee perfection. But it closes a dangerous loophole. No more hiding. No more fake records. No more waiting for a crisis before acting.

By 2026, the FDA plans to hire 200 new inspectors focused solely on foreign facilities. That’s a 40% increase in international inspection capacity. Combined with unannounced visits and stricter documentation rules, the system is finally aligning with the reality of global drug production.

The goal isn’t to punish foreign manufacturers. It’s to protect patients. Whether your medicine comes from a lab in New Jersey or a factory in Mumbai, it should meet the same standard. The FDA is finally making that happen.

What’s Next?

The FDA’s 2026 budget includes funding for digital inspection tools, AI-assisted data analysis, and real-time monitoring of supply chains. International partnerships are growing too. The FDA now shares inspection reports with Europe’s EMA, Japan’s PMDA, and Australia’s TGA. This isn’t just about U.S. safety-it’s about building global trust.

For now, the message is clear: if you make drugs for Americans, you’re no longer operating under a different set of rules. The bar is the same. The scrutiny is the same. And the consequences for falling short? They’re no longer delayed.