On May 6, the US Food and Drug Administration (FDA) revealed plans to expand its unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products for American consumers. The expansion could lead to all foreign facilities manufacturing FDA-regulated products being subject to these inspections. Traditionally, domestic facilities have received more unannounced inspections compared to foreign establishments, which have been given up to 12 weeks’ notice.
This initiative builds on the FDA’s Foreign Unannounced Inspection Pilot program in India and China. These two countries supply over a third of the foreign establishments serving the US market. The pilot program was launched in 2014, paused in 2015, and restarted in 2021 with annual funding from Congress. It aims to increase unannounced surveillance inspections of foreign drug establishments.
The announcement comes after President Donald Trump issued an executive order on May 5 titled “Regulatory Relief to Promote Domestic Production of Critical Medicines.” Among other directives, it instructs the FDA to enhance the risk-based inspection regime by August 3, 2025. This includes routine reviews of overseas manufacturing facilities involved in supplying US medicines, funded by increased fees on foreign facilities as allowed by law. Details on implementing these fees were not provided but could involve higher facility registration fees. The order also requires the FDA to disclose annually the number of foreign inspections with specifics by country and manufacturer.
There are concerns about how quickly this expansion can be implemented due to a historical shortage of investigators for foreign inspections and recent reductions in force affecting the FDA. These limitations might delay implementation and cause inconsistencies in enforcement. However, more frequent unannounced inspections mean companies must ensure continuous compliance at their foreign manufacturing operations or face operational disruptions.
The increased inspections could lead to significant findings by the FDA and enable it to use regulatory enforcement tools like Import Alerts to prevent noncompliant products from entering the US supply chain. While such actions might cause short-term drug shortages, they could improve product quality and safety over time.
This move aligns with another goal announced by the Trump administration: bringing pharmaceutical manufacturing back onshore to reduce US reliance on foreign-made pharmaceuticals. The White House’s executive order notes that barriers exist in establishing a domestic pharmaceutical supply chain due partly to more frequent unannounced inspections of domestic manufacturers compared to international ones. Increasing unannounced inspections abroad may level this disparity and support stronger domestic pharmaceutical production.
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