When you pick up a generic pill at your local pharmacy, you probably don’t think about where it was made. But over 80% of the active ingredients in U.S. medicines come from factories in India and China. And for years, those factories were inspected far less often - and far less rigorously - than those in the United States. That’s changing. As of 2026, the FDA is no longer treating foreign drugmakers as second-class citizens. The rules are the same. The standards are the same. And now, so are the inspections.
Same Rules, Different Reality
The FDA has required all drug manufacturers - whether in Ohio or Odisha - to follow Current Good Manufacturing Practices (CGMP) since the 1970s. These rules cover everything from how workers wash their hands to how data is recorded and stored. The goal is simple: no matter where it’s made, every pill must be safe, pure, and effective. But for decades, enforcement wasn’t equal. Domestic facilities got surprise inspections - no warning, no time to clean up. Foreign facilities? They often got 8 to 12 weeks’ notice. That gave factories time to fix problems, hide errors, or even temporarily hire extra staff just to impress inspectors. The result? In 2024, foreign facilities had more than twice the rate of serious violations compared to U.S. plants. Data integrity issues - like falsified lab records or deleted test results - showed up in 38.7% of foreign inspections. At home? Just 17.2%.Why It Matters
Generic drugs make up 90% of all prescriptions filled in the U.S. They’re cheaper, yes - but they’re not less important. A patient taking blood pressure medication, antibiotics, or insulin depends on that drug working exactly as it should. When a factory in India skips a purity test or a plant in China uses expired reagents, it doesn’t just risk a fine. It risks lives. The FDA’s 2024 inspection report showed contamination control failures in 22.4% of foreign facilities - nearly double the rate at U.S. sites. That’s not just paperwork. That’s bacteria in a clean room. That’s dust in a vial of injectable medicine. That’s a batch of pills that might never be labeled as defective - because the records were altered.The New Rules: Unannounced Inspections
On May 6, 2025, FDA Commissioner Marty Makary announced a major shift: unannounced inspections for foreign facilities would jump from 15% to at least 50% by Q2 2026. This wasn’t just policy. It was a response to public pressure, congressional hearings, and damning reports from ProPublica and other investigators. One case stuck out: Sun Pharma’s facility in India. The FDA banned it from exporting drugs in 2021 after finding serious violations. Yet, four of its drugs still made it into U.S. pharmacies. How? The system had loopholes. The FDA’s Office of Drug Evaluation sometimes overruled its own inspectors. That’s no longer allowed. Now, inspection findings are locked in. No exceptions.
What Foreign Manufacturers Must Do Now
If you’re a generic drugmaker in Hyderabad or Shanghai, the game has changed. You can’t just clean up before an inspection. You have to be clean every day.- Mock inspections are no longer optional. Experts say facilities should run them quarterly. Train staff to answer questions on the spot. Practice pulling records in under 10 minutes.
- Documentation must be real-time. No more handwritten logs that get copied later. Digital systems with audit trails are now the baseline.
- Contamination control is under a microscope. Air filters, gowning procedures, and water purity checks must be logged and verified daily.
- Refusing entry now triggers an automatic import alert. That means all your drugs get blocked - not just the ones under review.
How the U.S. Compares to Europe
The European Union doesn’t just inspect factories. It requires every batch of medicine to be signed off by a Qualified Person - a certified expert physically located in Europe who takes legal responsibility for quality. That person can’t be outsourced. They can’t be remote. They’re accountable. Brookings Institution has proposed this model for the U.S. It would mean U.S.-based importers have to designate their own Qualified Person to verify each shipment before it crosses the border. It’s a layer of accountability that doesn’t exist today. And while it’s not yet law, the momentum is growing. Senators Gillibrand and Scott raised the idea in April 2025 after uncovering cases where foreign manufacturing was linked to forced labor in China.
What’s Changing in 2026
The FDA isn’t just doing more inspections. It’s doing them smarter.- 200 new foreign inspection specialists are being hired by 2026 - a 40% increase in capacity.
- The FDA is sharing inspection data with Australia’s TGA, Japan’s PMDA, and the European Medicines Agency. If one agency finds a problem, others know.
- President Trump’s Executive Order 14135 (signed May 5, 2025) demands full parity between domestic and foreign inspections within 18 months.
What This Means for Patients
You might not notice the changes. But they’re there. The pills you take - whether for diabetes, depression, or high cholesterol - are now more likely to come from a facility that was inspected without warning. That means fewer falsified records. Fewer contaminated batches. Fewer recalls. The Generic Pharmaceutical Association says 42% of its members have already upgraded their quality systems since the May 2025 announcement. That’s not just compliance. That’s culture change.What’s Next?
The FDA’s goal isn’t just to catch bad actors. It’s to make them rare. By 2027, they expect foreign facility violations to drop by 30-40% if the new system holds. But there’s a risk: supply chains could get shaky. Evaluate Pharma warns that up to 20% of generic drug availability could dip in the short term as factories adjust. For now, the message is simple: if you make drugs for Americans, you’re held to the same standard as the factory next door. No exceptions. No advance notice. No second chances.Are foreign-made generic drugs safe?
Yes - but only if they come from facilities that meet FDA’s CGMP standards. Since 2025, the FDA has been conducting unannounced inspections at foreign factories to ensure those standards are met. While past inspections were often predictable and less thorough, the current system is designed to catch violations before drugs reach U.S. patients. The FDA reports that compliance has improved since the new policy took effect, and more drugs are now being held to the same standard as those made in the U.S.
How often does the FDA inspect foreign drug factories?
In 2025, the FDA conducted about 3,000 inspections of foreign facilities across 90+ countries. By 2026, at least half of those inspections will be unannounced - up from just 15% before. The agency plans to hire 200 new inspectors by 2026 to support this shift. Domestic factories, by contrast, have long been inspected at a rate of about 12,000 times per year, mostly without notice.
Why do most generic drugs come from India and China?
India produces about 40% of the active pharmaceutical ingredients used in U.S. generic drugs, and China supplies another 13%. This is due to lower labor and production costs, large-scale manufacturing capacity, and decades of investment in pharmaceutical infrastructure. The U.S. no longer manufactures most generic drugs domestically because it’s more expensive. But with tighter oversight, the FDA is ensuring quality isn’t sacrificed for cost.
What happens if a foreign factory fails an FDA inspection?
If a foreign facility is found to be in serious violation of CGMP standards, the FDA can issue a warning letter, block imports from that site, or even ban it from exporting to the U.S. altogether. In 2021, Sun Pharma’s facility in India was banned after repeated violations - but drugs from that site still entered the U.S. until the FDA changed its review process in 2025. Now, violations trigger automatic import alerts, and approvals require direct oversight from the Office of Inspections and Investigations.
Can the FDA inspect a foreign factory without permission?
The FDA doesn’t have legal authority to enter foreign soil. But it can refuse entry to any drug from a facility that refuses inspection. That means if a factory denies access to an FDA inspector - even once - the agency can block all shipments from that site. This is a powerful tool. In practice, no major manufacturer has refused an inspection since the new unannounced policy began.