Foreign Manufacturing of Generics: FDA Oversight and Standards in 2025

More than 90% of the generic drugs Americans take every day are made overseas-mostly in India and China. That’s not a secret. What’s less known is how those factories are inspected, and whether the system actually protects patients. Until recently, the FDA treated foreign drugmakers very differently from U.S.-based ones. That’s changing. And if you rely on generic medications, you need to understand what’s at stake.

Why foreign manufacturing matters

The U.S. doesn’t make most of its generic drugs anymore. About 80% of the active ingredients in pills, injections, and creams come from abroad. Finished products? Around 40% are made overseas. India supplies nearly half of those ingredients. China adds another 13%. These aren’t small players. Companies like Sun Pharma, Dr. Reddy’s, and Teva have factories that churn out billions of tablets a year for U.S. pharmacies.

The reason is simple: cost. Labor, land, and regulatory overhead are lower overseas. But lower cost doesn’t mean lower quality-on paper. The FDA says all manufacturers, no matter where they’re located, must follow the same rules: Current Good Manufacturing Practices, or cGMP. These rules cover everything from how clean the floors are to how data is recorded. If a pill is made in Ohio or Odisha, it should meet the same standard.

But in practice, it didn’t.

The inspection gap

For years, the FDA did about 12,000 inspections of U.S. factories each year. Most were unannounced. Inspectors showed up without warning, walked through the facility, checked records, and asked questions on the spot. If something looked off, they documented it right away.

Meanwhile, inspections of foreign plants? Only about 3,000 a year. And here’s the kicker: manufacturers often got 8 to 12 weeks’ notice. That’s enough time to clean up, fix records, train staff, and hide problems. It’s like inviting an inspector to your house after you’ve spent a week scrubbing the floors and hiding the mess.

The result? Foreign facilities were more than twice as likely to have serious violations. In 2024, 45% of foreign inspections found issues with data integrity-like fake test results or deleted records. At U.S. plants, that number was just 17%. Contamination problems? 22% of foreign sites had them. Only 10% of domestic ones did.

This wasn’t a glitch. It was a system.

What changed in May 2025

On May 6, 2025, FDA Commissioner Marty Makary announced a major shift: unannounced inspections for foreign factories would jump from 15% to at least 50% by mid-2026. That’s not a tweak. It’s a full reset.

The move came after years of pressure. Senators Kirsten Gillibrand and Tim Scott sent a letter in April 2025 demanding answers after reports surfaced that the FDA had allowed drugs from flagged facilities to still enter the U.S. One example: Sun Pharma’s facility in India was banned in 2021 for falsifying data-yet four of its drugs were still approved for sale in the U.S. two years later.

President Trump’s Executive Order 14135, signed the day before, forced the FDA to eliminate the inspection gap within 18 months. The agency responded by hiring 200 new inspectors for international sites and doubling down on real-time data reviews. No more advance notice. No more soft landings.

Now, if you’re a foreign manufacturer, you could get a knock on the door with just 24 to 48 hours’ warning. Refuse entry? Your entire shipment gets blocked. No appeals. No delays.

What the FDA looks for during inspections

An FDA inspector doesn’t just check for dirty floors. They dig into your systems. Here’s what they’re really looking for:

• Data integrity: Are test results real? Are logs altered? Are electronic records backed up and unchangeable?
• Contamination control: Are air filters working? Are cleaning procedures documented and followed? Are workers trained to avoid cross-contamination?
• Equipment maintenance: Are machines calibrated? Are repair logs kept? Are outdated tools still in use?
• Quality control: Do you test every batch? Do you reject batches that don’t meet specs? Or do you just approve them to meet deadlines?
• Documentation: Is every step written down? Are signatures real? Are dates accurate?

They use Form 483 to list any problems. A single Form 483 doesn’t mean a shutdown. But if you get one, you have 15 days to fix it-or risk a warning letter. Two warning letters? Your drugs get barred from the U.S. market.

How foreign manufacturers are adapting

Companies in India and China are scrambling. A PDA survey in early 2025 found that 68% of foreign manufacturers expect compliance costs to rise 15-25% because of the new inspection rules. Smaller factories, especially those with fewer than 50 employees, are struggling the most.

Some are hiring ex-FDA inspectors as consultants. Others are running weekly mock inspections. One Indian plant started doing daily quality audits-something they never did before. The Generic Pharmaceutical Association says 42% of its members have already added new training programs or upgraded their documentation software.

Experts say the learning curve takes 6 to 9 months. You can’t just change a policy. You have to change a culture. That means teaching every lab tech, every shift supervisor, every manager that lying about data isn’t a shortcut-it’s a criminal offense.

Could the U.S. copy the EU system?

The European Union doesn’t just inspect factories. It requires every drug batch to be signed off by a Qualified Person-a trained professional who lives in Europe and takes legal responsibility for the product’s safety before it leaves the factory.

That’s a big difference. In the U.S., the manufacturer says, “We’re good.” In the EU, an independent expert says, “I’ve checked it. This is safe.”

Brookings Institution researchers argue the U.S. should adopt something similar for imported drugs. Instead of relying on the foreign factory’s word, make the U.S. importer take responsibility. Require them to hire a Qualified Person who certifies each batch before it clears customs.

It’s not a perfect fix. But it adds a layer of accountability. Right now, the FDA is the only check. With 12,000 domestic inspections and only 3,000 foreign ones, they’re stretched thin. A third-party gatekeeper could help close the gap.

What this means for patients

You might think, “I take generic pills. Why should I care?”

Here’s why: if a factory falsifies data, you could get a pill that doesn’t dissolve properly. Or one with too much or too little of the active ingredient. In rare cases, that leads to treatment failure-or worse.

In 2023, the FDA recalled 127 batches of generic blood pressure meds because they contained a cancer-causing impurity. All came from overseas. In 2024, another recall affected 4 million tablets of generic metformin after contamination was found in the raw material.

The FDA’s new policy won’t stop every bad drug. But it makes it harder to hide. It forces factories to be honest-not just when an inspector is coming, but every day.

What’s next?

By 2026, the FDA plans to inspect at least half of all foreign drug plants without notice. They’ll also expand sharing of inspection data with regulators in Europe, Japan, and Australia. If a plant fails in India, the FDA will know-and so will the EMA or PMDA.

Some analysts warn this could cause short-term shortages. If 15-20% of foreign facilities get shut down or delayed while they fix problems, supply chains will ripple. But long-term? The goal is safer drugs, not fewer options.

The bottom line: generic drugs aren’t cheap because they’re low quality. They’re cheap because they’re made at scale. But scale can’t come at the cost of safety. The FDA’s new approach isn’t about punishing foreign companies. It’s about making sure every pill, no matter where it’s made, works the way it’s supposed to.