Foreign Manufacturing of Generics: FDA Oversight and Standards in 2025

Why Foreign-Made Generic Drugs Are Under Fire

Over 90% of generic drugs in the U.S. come from factories overseas-mostly in India and China. These pills, capsules, and injections are cheaper than brand-name drugs, but their safety depends entirely on how well they’re made. The FDA says all manufacturers, no matter where they’re located, must follow the same rules: Current Good Manufacturing Practices (CGMP). But in practice, the rules haven’t been enforced the same way. Until recently, U.S. factories got surprise inspections. Foreign ones got weeks of notice. That meant some facilities had time to clean up, hide problems, or even fake records before inspectors showed up.

What CGMP Actually Means for Drug Factories

CGMP isn’t just a checklist. It’s a full system. Every step-from mixing raw chemicals to packaging pills-must be documented, tested, and controlled. Workers need proper training. Equipment must be cleaned and maintained. The air in the room can’t have too much dust. Water used in production must be pure. And every batch of medicine must be tested before it leaves the factory. If any of this fails, the drug could be weak, contaminated, or even dangerous.

The FDA checks these things during inspections. They look at logs, interview staff, and test samples. If they find problems, they issue a Form 483-a list of violations. Serious ones can lead to warning letters, import bans, or even criminal charges. The problem? Foreign facilities were failing at more than twice the rate of U.S. ones. In 2024, 45% of foreign inspections found serious issues like falsified data or poor contamination control. At U.S. plants, that number was under 20%.

The Double Standard in Inspections

For years, the FDA did about 12,000 inspections a year in the U.S.-almost all unannounced. Meanwhile, they only did 3,000 inspections overseas, and most came with 8 to 12 weeks’ notice. That’s not oversight. That’s a heads-up. Companies could stockpile clean records, fix broken machines, or temporarily clean up labs just before inspectors arrived. Real problems stayed hidden.

That changed in May 2025. The FDA announced it would start unannounced inspections at foreign factories, just like in the U.S. The goal? To catch bad actors before they ship unsafe drugs to American pharmacies. FDA Commissioner Marty Makary said it bluntly: “Unannounced inspections will expose those who falsify records or conceal violations.”

By mid-2026, at least half of all foreign inspections will be unannounced. That’s up from just 15% before. This isn’t a small tweak-it’s a complete overhaul of how the FDA protects patients.

Why India and China Are the Focus

India makes 40% of the active ingredients in U.S. generic drugs. China makes another 13%. Together, they supply the bulk of medications Americans take every day-antibiotics, blood pressure pills, diabetes drugs. But they’re also where most violations are found.

ProPublica’s 2024 investigation found that even after the FDA banned a major Indian factory, Sun Pharma, from exporting drugs in 2021, four of its medicines still made it into the U.S. market. How? The FDA’s approval system had gaps. Some approvals were overridden by internal teams, despite clear safety concerns raised by inspectors.

These aren’t isolated cases. In early 2025, multiple Indian and Chinese manufacturers received FDA warning letters for failing to control contamination, using outdated testing methods, or not properly training staff. The message was clear: the old system was broken.

What’s Changing in 2025 and Beyond

The FDA isn’t just increasing unannounced inspections. They’re hiring 200 new inspectors by 2026 to handle the workload. They’re also expanding partnerships with regulators in the EU, Japan, and Australia. If one agency finds a problem, others get the report. That helps close loopholes.

President Trump’s Executive Order 14135, signed in May 2025, forced the FDA to eliminate the inspection gap within 18 months. The agency responded with a plan: ramp up unannounced visits, improve training for inspectors, and push for stronger accountability from importers.

One idea gaining traction? Copying the EU’s “Qualified Person” model. In Europe, a certified expert must sign off on every batch before it’s sold. That person is legally responsible. If something goes wrong, they’re on the hook. U.S. importers don’t have that same responsibility. Experts at Brookings Institution say adding this layer could cut foreign facility violations by 30-40%.

How Foreign Manufacturers Are Adapting

Companies in India and China are scrambling to get ready. A PDA survey found 68% of foreign manufacturers expect compliance costs to rise 15-25% because of the new rules. Smaller factories, especially, are struggling to afford the upgrades needed for real-time documentation, better air filtration, and staff training.

Industry consultants are telling factories to do three things: run mock inspections every quarter, update all documentation daily, and train staff to handle surprise visits. One company in Hyderabad now conducts weekly internal audits. Another in Shanghai hired a former FDA inspector as a consultant. These aren’t luxuries anymore-they’re survival tactics.

Generic drug makers who don’t adapt risk having their products blocked at the border. The FDA can issue an import alert, which stops all shipments from a facility until the problems are fixed. That can mean lost revenue, delayed shipments, and damaged reputation.

What This Means for Patients

For you, the patient, this isn’t about politics or trade deals. It’s about whether the pill you take every morning actually works. A weak antibiotic won’t kill the infection. A contaminated blood pressure pill could cause a stroke. A fake diabetes drug could lead to organ damage.

The FDA’s new approach is meant to fix that. More unannounced inspections mean fewer hidden problems. Stronger oversight means safer drugs. But change takes time. In the short term, some generic medications might be harder to find. Evaluate Pharma predicts a 15-20% drop in availability for certain drugs in 2025-2026 as factories catch up.

That’s not a failure. It’s a correction. The system was letting unsafe drugs slip through. Now, it’s being fixed-even if it’s messy.

What You Can Do

You don’t need to become a drug inspector. But you can stay informed. If your pharmacy switches your generic brand unexpectedly, ask why. If a drug seems less effective or causes new side effects, report it to the FDA’s MedWatch program. Patient reports help the agency spot patterns.

Also, don’t assume “made in the U.S.A.” is always safer. Many U.S.-branded drugs still use foreign-made ingredients. The key isn’t where it’s made-it’s whether the maker follows the rules. And now, thanks to new inspections, that’s harder to fake.