FDA Expands Unannounced Foreign Inspections: Are You Prepared for a Knock at the Door?

European MedTech companies are facing a fundamentally new reality. The FDA has formally announced an expansion of unannounced foreign inspections, ending the long-standing advance-notice practice and increasing the overall number of overseas audits. With global oversight intensifying, the question is not whether the FDA will come, but whether your organization can withstand an inspection at any moment.

The Double Standard Just Ended
For years, overseas manufacturers operated under an unspoken advantage: advance notice before FDA inspections. That advantage has now been removed. The FDA has publicly committed to expanding the use of unannounced inspections abroad and applying the same level of scrutiny to foreign sites as to U.S. facilities. This shift means European firms must assume that inspection readiness is continuous, not event-based.

Foreign Inspections Are Increasing, and Becoming More Aggressive
Foreign inspections fell during the pandemic, but the rebound has been sharp. FDA prioritizes high-risk devices, new market entrants such as recent 510(k)s and De Novo classifications, and firms with a history of observations. The agency has previously roughly 1000 domestic (U.S.) inspections and 250 foreign (non-U.S.) inspections each year and has now announced its intent to apply the same level of regulatory oversight and scrutiny for foreign- as domestic companies.

Since the pandemic, the share of foreign inspections has risen to almost 25%, a number not seen since the previous peak of 2015. As 2025 is still ongoing, and has coincided with a prolonged government shutdown limiting FDA resources, the 2025 YTD data is not fully comparable with previous years.

FDA Arrives Focused, and Finds What’s Weak
Unannounced inspections are designed to expose real-world compliance, not staged readiness. The FDA’s QSIT methodology remains tight and targeted, CAPA, Design Controls, Production & Process Controls, and Management Control, but expectations for rigor, traceability, and data integrity have never been higher.

Minor inconsistencies in CAPA trending, vague design-history narratives, unclear validation rationales, or documentation that cannot be retrieved immediately are all red flags that can escalate rapidly into observations or enforcement action.

Despite the previous advance warning system, foreign inspections have over the past three years uncovered serious deficiencies on average four times (4X) as often as domestic ones, a trend the FDA is determined to address with stronger, less predictable oversight.

Over 2023-2025, foreign inspections by the FDA have, on average, been nearly four (4) times more likely to result in Official Action Indicated (OAI) classifications than domestic inspections.
Official Action Indicated (OAI) classification indicates a facility is in an unacceptable state of compliance.

When the Door Opens, It’s Too Late to Prepare
Unannounced inspections eliminate the buffer that many companies have relied on and reward companies who operate in a state of real readiness. They expose those that rely on “inspection theater” or last-minute clean-ups. Even companies with otherwise strong QMS frameworks often struggle under pressure when readiness is not embedded in daily operations.

This Isn’t Just Compliance, It’s Survival
FDA readiness now defines market access, resilience, and reputation. Companies that fail inspections face operational disruption, delayed launches, and credibility loss. Those who build continuous readiness gain trust and speed in the world’s most important MedTech market.

The question is no longer if FDA will come, but when and how ready you are when they do?