The U.S. Food and Drug Administration (FDA) has announced plans to expand its use of unannounced inspections at foreign facilities producing food, essential medicines, and medical products destined for the U.S. market. This move builds on the agency’s pilot programs in India and China and represents a significant step toward aligning foreign and domestic oversight standards.
“For too long, foreign companies have operated under a double standard—receiving advance notice ahead of inspections, unlike their U.S. counterparts,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “That ends today. This expansion is part of a broader effort to restore consistency, transparency, and trust in the FDA’s global inspection program.”
Currently, the FDA conducts approximately 15,000 inspections annually, including around 3,000 at foreign facilities. While domestic manufacturers are typically subject to unannounced visits, foreign firms often receive notice weeks in advance—yet are still found to have serious compliance issues more than twice as often. This discrepancy has raised concerns about the reliability and integrity of global supply chains.
The expanded approach aims to close that gap. Unannounced inspections will enhance the FDA’s ability to identify potential violations such as falsified records, concealed deficiencies, or unsafe practices before they impact U.S. consumers. The agency emphasized that it is authorized to take regulatory action against any firm that delays or obstructs an inspection, or denies entry to FDA inspectors.
In addition to increasing unannounced inspections, the FDA will reassess its foreign inspection policies to strengthen impartiality. This includes new guidance advising FDA staff to decline travel accommodations offered by regulated entities, such as lodging or local transportation, to preserve the independence of the inspection process.
“The FDA’s science-based inspections generate critical, real-time data that support regulatory decision-making and help keep American families safe,” said Michael Rogers, FDA Assistant Commissioner for Inspections and Investigations. “Even inspections that identify no violations play an important role in strengthening our oversight system.”
With these changes, the FDA signals a more assertive enforcement posture—one that ensures all companies, regardless of geography, are held to the same high standards for safety, quality, and compliance.
For more information, visit the FDA Inspections Database FAQs and Inspections Yield Valuable Results.