On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a substantial increase in unannounced inspections at foreign manufacturing facilities that manufacture medical products for U.S. import. This initiative is a result of a White House Executive Order directing agencies to pursue enhanced domestic drug production and support FDA’s risk-based inspection strategy for foreign facilities. The FDA will build on its Foreign Unannounced Inspection Pilot Program, which has been in place in China and India — the top 2 countries with FDA-regulated drug establishments. This initiative aims to bridge the regulatory disparity between domestic US manufacturing sites and foreign sites since routine FDA inspections in the US are usually unannounced — whereas most overseas inspections involve advance coordination.
This policy shift is happening in the context of increasing pressure to re-establish rigorous foreign inspections, primarily in China, where FDA inspections have already ramped up after the pandemic. In FY 2024, the FDA conducted over 200 inspections of drug and device manufacturing sites in China — a significant increase from 61 inspections in FY 2023.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.