FDA Announces Stricter Unannounced Inspections for Foreign Manufacturing Facilities

On May 6, the U.S. Food and Drug Administration (FDA) announced a significant policy shift: it will begin conducting more unannounced inspections at foreign manufacturing facilities that produce food, essential medicines, and other medical products for U.S. consumers. This change expands on the FDA’s pilot program in India and China and seeks to hold foreign firms to the same regulatory standards as domestic manufacturers. As FDA Commissioner Martin A. Makary stated, “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today.”

The announcement added, “In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.”

The FDA emphasized that it already conducts about 12,000 domestic and 3,000 foreign inspections annually, but the advance notice given to foreign firms has often undermined the effectiveness of those inspections.

Despite receiving prior warning, foreign companies have still shown significantly more compliance deficiencies than domestic ones, highlighting the need for stricter oversight. Unlike in the U.S., where inspections are typically unannounced and cannot be negotiated, foreign inspections have often been scheduled in advance. The FDA aims to end this discrepancy, stating that no firm should be allowed to “delay, deny, or limit an inspection,” nor refuse entry during an unannounced visit.

With this shift, the FDA is enhancing its capacity to ensure that imported goods are safe and lawfully produced. “These inspections provide real-time evidence and insights that are essential for making fact-based regulatory decisions to protect public health,” said Michael Rogers, FDA Assistant Commissioner for Inspections and Investigations. The initiative underscores the agency’s commitment to a “stronger, smarter” enforcement strategy that prioritizes the safety and trust of American consumers.