FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an expansion of its unannounced inspection program to now include foreign manufacturing sites. This change will directly impact companies exporting pharmaceuticals and other regulated products into the U.S.
If you rely on international partners or operate your own facilities abroad, this update could change how you prepare for inspections. Keep reading to understand the key changes, potential risks, and how to ensure you remain compliant.
Why is the FDA expanding unannounced inspections?
The FDA wants to strengthen oversight of global supply chains. Previously, inspections at foreign sites were usually pre-announced, which gave facilities time to prepare. However, reports of quality issues and falsified records abroad led the FDA to act. By reducing advance notice and increasing surprise visits, the agency hopes to observe day-to-day operations more accurately.
This change supports the FDA’s broader mission to protect product quality and patient safety. Because more than 70% of active pharmaceutical ingredients and many finished drugs come from outside the U.S., stronger foreign oversight is essential.
What does this mean for your business?
If your supply chain includes foreign manufacturers, your business could feel the impact. A non-compliant facility abroad may trigger delays, import holds, or even product recalls. These outcomes can damage your brand and reduce revenue.
For companies with foreign operations, the biggest shift is the need for constant inspection readiness. Relying on advance notice is no longer safe. FDA unannounced inspections can happen at any time. If your operations fail to demonstrate consistent quality practices during a surprise visit, your company may face Form 483 observations or even stricter enforcement.
How to stay compliant
The key to managing this change is maintaining constant inspection readiness. Here’s how you can prepare:
- Strengthen your quality management system (QMS): Ensure your procedures are documented, up to date, and aligned with U.S. FDA expectations.
- Train staff regularly: Your team should understand their roles during inspections and how to respond professionally and accurately.
- Conduct internal audits: Regular reviews can help identify and fix gaps before the FDA does.
- Review supplier agreements: If you outsource manufacturing, make sure your partners are held to the same quality standards and are also prepared for unannounced inspections.
Working with a regulatory partner can help you stay ahead of these requirements. At Quality Smart Solutions, we support companies with inspection readiness, SOP development, mock audits, and ongoing compliance strategies.
The bottom line
The FDA’s move to expand unannounced inspections to foreign manufacturing facilities is a signal for businesses to take inspection preparedness seriously, no matter where production happens. It’s no longer a matter of if you’ll be inspected without notice, but when.
To learn more about this update directly from the FDA, read the full press release.
Need help preparing for potential FDA inspections or reviewing your quality systems? Contact us or fill out the form below to book a consultation with one of our regulatory experts.
