Unannounced FDA Foreign Inspections Expand as Administration Pushes Domestic Manufacturing
Domestic manufacturing is about to get fast-tracked while foreign facilities face surprise inspections. Are you ready?
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The FDA announced on Tuesday that it will expand unannounced inspections at foreign manufacturing facilities. This move comes just one day after President Trump signed an executive order aimed at promoting domestic pharmaceutical production through regulatory streamlining and enhanced oversight of foreign manufacturers, along with a companion fact sheet.
Here’s a brief look at what’s happening—and what we recommend teams do in light of these announcements.
The FDA is overhauling its foreign inspection protocol
The FDA's announcement marks a clear end to what Commissioner Martin Makary called a "crazy system" where "American pharma manufacturers in the United States are put through the wringer with inspections, and the foreign sites get off easy with scheduled visits."
Lawmakers have consistently criticized the FDA’s foreign inspection program, arguing that notifying foreign manufacturers ahead of inspections puts domestic manufacturers at a disadvantage, as they face unannounced visits back at home. In its FY2022 spending bill, Congress instructed the FDA to launch a pilot program for unannounced inspections in India and China, later expanding it in FY2023.
By expanding its unannounced foreign inspection program beyond the initial pilot in India and China, the agency now wants to level the regulatory playing field between domestic and foreign manufacturers.
This obviously brings major implications for both foreign and domestic pharmaceutical operations, especially considering the agency's own data showing that despite giving foreign facilities weeks to prepare for inspections, the FDA still discovered serious deficiencies more than twice as often as during domestic inspections.
While the FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections annually across more than 90 countries, the agency did not specify exactly how many unannounced foreign inspections it plans to conduct or which additional countries would be targeted beyond India and China.
The announcement comes during a period of significant transition at the agency. Several top inspection officials are departing, including Michael Rogers, Assistant Commissioner for Inspections and Investigations, who will retire on May 14 after 34 years at the FDA. Other recent departures include Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate (OHADI), and Nancy Rolli, deputy office director for strategic oversight at OHADI.
These personnel changes come against the backdrop of the agency's recent reduction-in-force that reportedly led to the layoff of thousands of FDA staff on April 1, including some responsible for inspection and travel logistics. Recent reports indicate the agency is now attempting to rehire some of the affected travel staff.
A new executive order targets pharma supply chain security
The FDA's announcement follows President Trump's May 5 executive order, which aims to reduce regulatory barriers to domestic pharmaceutical manufacturing while increasing oversight of foreign facilities.
The order highlights concerns about the time required to build pharmaceutical manufacturing facilities in the United States—currently estimated at 5 to 10 years—which the White House deemed "unacceptable from a national security standpoint."
Key provisions of the executive order direct:
The FDA to review and eliminate duplicative or unnecessary requirements in regulations and guidance pertaining to domestic pharmaceutical manufacturing within 180 days.
The FDA to develop improvements to its risk-based inspection regime for overseas facilities within 90 days, funded by increased fees on foreign manufacturing facilities.
The FDA to provide clearer guidance on site changes, including moving production from foreign to domestic facilities.
The EPA to update regulations and guidance applying to the approval of new and expanded manufacturing capacity.
The designation of a single point of contact within agencies to coordinate permit applications for pharmaceutical manufacturing facilities.
During the signing ceremony, President Trump emphasized national security concerns, stating, "We don't want to be buying our pharmaceuticals from other countries because if we're in a war, we're in a problem, we want to be able to make our own."
Inspection policy changes
Beyond expanding unannounced inspections, the FDA also announced it will change its inspection policies, including barring staff from accepting lodging and transportation arrangements from regulated industries—a move designed to "maintain the integrity of the oversight process."
Commissioner Makary also indicated a shift in how inspections will be conducted, stating, "We are not going to have our inspectors hanging out for three to four weeks; they are going to get in and out, and we are going to do more inspections with the same amount of resources as a result."
Implications and a few recommendations
The expansion of unannounced foreign inspections, combined with the executive order's regulatory reforms, creates both challenges and opportunities for pharmaceutical manufacturers.
Here are a few things we recommend RA/QA and compliance teams start considering now.
Rethink inspection readiness
The days of “cyclical” preparation for foreign inspections might be more or less over. Foreign facilities must now pivot to a continuous state of inspection readiness that mirrors what domestic sites have long experienced. This means fundamentally reimagining how facilities approach compliance on a day-to-day basis.
Rather than ramping up preparations when an inspection is imminent, foreign sites should institute regular mock inspection protocols and conduct unannounced internal audits across all shifts, including weekends and overnight operations. Talk to us if you need auditing or mock inspection support.
Make sure you have clear and trained on communication protocols for when inspectors arrive without notice to prevent the confusion that can compromise first impressions. Personnel at all levels—from reception staff to quality executives—should understand their specific roles during unannounced inspections.
Documentation systems will need to move from periodic review cycles to continuous or near-continuous updating protocols that make sure your records are constantly audit-ready.
This shift requires training all personnel—from executive leadership to production floor staff on all shifts—to handle impromptu regulatory visits. Many foreign facilities would benefit from conducting thorough gap assessments that benchmark their current readiness against the FDA's expectations for domestic facilities, which have always operated under the assumption that inspectors could arrive at any moment. Again, this is what we do for companies every day. Talk to us if you need to run a robust gap analysis.
Also, make sure you have clear internal policies regarding transportation and accommodations, which will prevent problems during the often-hectic period when inspectors first arrive. Make sure you’re balancing hospitality with regulatory integrity, recognizing that the dynamics of investigator interactions might be different going forward.
Consider your supply chain
The dual forces of higher foreign inspection scrutiny and incentivized domestic production should drive firms to reassess their supply chains. Run a vulnerability analysis of your supplier network, and pay particular attention to those in regions likely to face heightened FDA scrutiny.
Also, now is the time to do actual contingency planning. No more theoretical exercises; firms will need concrete action plans for responding to potential disruptions at foreign manufacturing sites. The companies we see take this the most seriously typically have dual-sourcing strategies that incorporate at least one domestic supplier for critical components (if one exists) to provide redundancy.
Strengthen your documentation and data integrity program
Moving to unannounced inspections places unprecedented importance on robust data integrity programs, particularly at foreign facilities, where data integrity tends to be a particular weak point.
Having audited many foreign manufacturing sites, our number one recommendation is here to centralize your document repositories to make sure there’s immediate access to all required records—regardless of when an inspector arrives. This should include a data reporting system for APIs that fully comply with section 510(j)(3) of the FD&C Act, as the executive order specifically targets improved enforcement in this area.
Plan for facility changes
Quality and regulatory affairs teams should closely monitor for the FDA's forthcoming "clearer guidance regarding the requirements or recommendations for site changes." Those who prepare submission templates and protocols for expedited transfers from foreign to domestic production will gain valuable time advantages here.
Also, consider participating in the FDA's "early technical advice" programs, which the executive order specifically directs the agency to expand.
5 things to do right now
In light of these developments, here’s a quick action plan.
Conduct an unannounced mock inspection at your foreign facilities. Don't warn site management; assess how your team handles a surprise visit and identify immediate vulnerabilities that could be exposed during an FDA unannounced inspection.
Perform a data integrity risk assessment. Focus specifically on areas where preparation time has previously masked compliance issues, such as batch records, laboratory controls, and computer system validation documentation.
Review and update your inspection management procedures. Make sure protocols clearly define roles for all personnel during unannounced inspections and eliminate any procedures that assume advance notice.
Map your foreign supply chain vulnerabilities. Identify your suppliers in high-risk locations that may face increased FDA scrutiny and develop specific contingency plans for each critical material sourced exclusively from overseas facilities.
Document current regulatory pain points for domestic operations. Create an inventory of regulatory hurdles affecting your U.S. manufacturing operations to position your company to quickly capitalize on forthcoming FDA and EPA streamlining initiatives.
Looking ahead
While the agency has not provided specifics on how many unannounced inspections it plans to conduct or in which additional countries, the direction is clear: foreign facilities will face increased scrutiny and less opportunity to prepare for regulatory visits.
Meanwhile, the executive order's focus on streamlining domestic manufacturing approvals signals potential opportunities for companies considering reshoring production. Quality and compliance teams should closely monitor forthcoming guidance from both FDA and EPA on how these streamlining efforts will be implemented.
The success of these initiatives will obviously depend on the FDA's ability to overcome logistical challenges in conducting unannounced foreign inspections and the agency's capacity to rebuild its inspection workforce following recent staff reductions. For industry, the key will be adaptability and a renewed commitment to continuous inspection readiness rather than reactive preparation.
Talk to us if you need auditing, gap analysis, or mock inspection support.
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