On May 6, 2025, the U.S. Food and Drug Administration (FDA or Agency) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products marketed to American consumers and patients. According to the announcement, FDA plans to build on the Agency’s existing Foreign Unannounced Inspection Pilot Program for India and China with the aim of “ensur[ing] that foreign companies in any country will receive the same level of regulatory oversight and scrutiny as domestic companies.”
Historically, FDA has often provided foreign facilities with advance notice of routine surveillance inspections due to the logistical challenges of planning foreign inspections, including travel arrangements, visa requirements, and arrangements for interpreters. Additionally, FDA’s statutory inspectional authority — 21 U.S.C. 374 — does not apply abroad, meaning FDA usually coordinates with local health authorities in advance of conducting an inspection. By comparison, domestic sites typically receive no advance notice of surveillance inspections. According to FDA Commissioner Martin Makary:
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.
FDA’s announcement aligns with the Trump administration’s efforts to increase oversight of foreign manufacturers while promoting domestic manufacturing, including through the recent executive order (EO) to promote domestic production of critical medicines. Among other things, the EO directs the FDA Commissioner to “improve” the Agency’s risk-based inspection model to facilitate more surveillance inspections of foreign manufacturers. According to the EO, the increase in inspections of foreign facilities should be funded by increased facility fees for foreign facilities. In addition, FDA Commissioner Makary announced earlier this week that FDA will cut the length of foreign inspection trips.
From a practical perspective, FDA faces challenges in scaling up unannounced inspections. Staffing shortages remain a significant hurdle, as the Agency continues to report persistent vacancies among investigators specializing in foreign inspections. FDA had been exploring strategies to recruit and retain qualified investigators, including offering higher salaries and additional incentives for overseas assignments. However, the recent reductions in force across FDA and the focus on cost-cutting may affect these goals.
Setting these practical challenges aside, this announcement signals the Trump administration’s intention to increase scrutiny of foreign manufacturers. The previous Unannounced Inspection Pilot Program in India and China led to a significant increase in enforcement activity by FDA, including Import Alerts, warning letters, and applications being held up or not approved due to inspectional issues identified at foreign facilities. Coupled with FDA’s robust enforcement toolkit for all foreign manufacturers — for instance, Import Alert — inspection readiness is more important than ever, and foreign manufacturers should take proactive steps to be inspection-ready every day. This includes designating and training an inspection team, performing internal audits, and strengthening documentation practices.
Sidley’s team of FDA enforcement lawyers and former FDA investigators and regulatory compliance experts are available to assist your team with preparing for unannounced FDA inspections and other compliance and regulatory matters.
