On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. The FDA stated that this new inspection strategy will ensure that foreign manufacturers receive the same level of oversight and regulatory scrutiny as domestic companies. Key aspects of the FDA’s plan include:
- Increased Frequency: The FDA will increase the frequency of unannounced inspections at foreign facilities.
- Elimination of Double Standard: The FDA stated that the move ensures that foreign manufacturers are held to the same standards and oversight as domestic companies.
- Exposing Bad Actors and Ensuring Safe Prescription Drugs: The FDA explained that unannounced inspections will help expose bad actors (e.g., those who falsify records or conceal violations) and ensure that every product entering the U.S. is safe, legitimate and honestly made.
- Increased Enforcement Activity: The FDA emphasized that it is authorized to take regulatory action against any company that attempts to delay, deny or limit an unannounced inspection.
Read on to learn more about the FDA’s new policy and key considerations for stakeholders.