The US Food and Drug Administration (FDA) is intensifying its oversight of foreign drug manufacturing facilities in response to longstanding challenges in inspection practices, staffing shortages and a significant inspection backlog. Recent policy changes—including an executive order signed by President Donald J. Trump on May 5, 2025—signal a strategic shift toward enhancing domestic manufacturing and aligning foreign inspection standards with those applied to US facilities.
Key Issues
Inspection Disparities
Historically, foreign drug manufacturing establishments have received advance notice of FDA inspections, allowing them to address potential issues before inspectors arrive. In fiscal year 2023, nearly 90% of FDA's foreign inspections were preannounced, in contrast with the unannounced inspections typically conducted at US facilities. This discrepancy has raised concerns about the effectiveness of foreign inspections in identifying genuine compliance issues. Despite advance notice, FDA investigators have continued to uncover serious deficiencies abroad—more than twice as often as in domestic inspections—including instances of document destruction during inspections.
Inspection Backlog
The COVID-19 pandemic led to a suspension of most FDA inspections beginning in March 2020, with regular international visits resuming only in 2022. As of May 2024, approximately 2,000 pharmaceutical manufacturing firms had not been inspected by FDA staff since before the pandemic. This backlog includes over 340 plants in India and China, which are major sources of drug ingredients for the U.S. market. According to FDA guidelines, factories uninspected for five or more years are considered a significant risk and prioritized for mandatory inspection.
Workforce Challenges
As of June 2024, the FDA faced 225 vacancies in its inspection workforce—nearly four times the pre-COVID number. Factors contributing to the shortfall include extensive travel requirements (up to 50% of the time), lower starting salaries compared to industry roles, and increased competition from the private sector, where former inspectors can earn more than double their FDA salary. These challenges have been compounded by a recent reduction in force at the FDA, which eliminated a number of positions and further strained inspection capacity. As of June 2024, there were significant vacancies among FDA drug manufacturing investigators, particularly in its offices in China and India.
Strategic Responses
Expansion of Unannounced Inspections
The FDA plans to expand the use of unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and other medical products for the US market. This initiative—announced on May 6, 2025—is intended to address the “double standard” between domestic and foreign inspections and to expose non-compliant operations. FDA Commissioner Marty Makary has stated that these efforts are designed to create parity between domestic and foreign oversight and to root out falsification and concealment of quality control violations.
Increased Fees and Inspections
President Trump's May 5, 2025, executive order directs the FDA to increase both user fees and the number of inspections of foreign manufacturing plants. The order forms part of a broader initiative to encourage domestic pharmaceutical manufacturing and includes a mandate to strengthen enforcement of active pharmaceutical ingredient (API) source reporting requirements for foreign drug producers.
Evaluation of Inspection Policies
In February 2024, prior to the current administration, the FDA announced that it would evaluate its inspection-related policies and practices with the goal of enhancing the integrity and effectiveness of its foreign inspection program. Proposed changes included formal guidance empowering investigators to refuse travel accommodations (such as lodging and transportation) offered by inspected entities, to preserve the independence of oversight efforts. The agency also reaffirmed its authority to take enforcement action against facilities that delay, deny, limit, or refuse inspection.
Addressing the Inspection Backlog
Also in 2024, the FDA published a plan to address the pandemic-era inspection backlog in response to GAO recommendations. The plan outlines a risk-based strategy to prioritize overdue inspections and mitigate gaps in oversight.
Utilization of Alternative Tools
To maintain regulatory oversight during the pandemic, the FDA relied on tools such as record requests, virtual site evaluations, and foreign regulator reports. The Consolidated Appropriations Act of 2023 included a provision for FDA to conduct additional work on developing foreign drug inspection program and explore further use of alternative inspection tools.
Exploring Alternative Monitoring Approaches
The FDA and other agencies have considered broader reforms to supplement traditional inspections. In one pilot program, the US Department of Defense partnered with a private lab to test prescription drugs for contaminants—an approach common in Europe. Experts have also proposed incentivizing US pharmacy chains and distributors to source products only from high-quality manufacturers, thereby extending responsibility for supply chain integrity beyond the FDA.
Implications for Stakeholders
Stakeholders in the pharmaceutical and health care industries should consider the following:
- Increased Regulatory Exposure: Expanded unannounced inspections and intensified enforcement may raise compliance risks for foreign manufacturers and for those entities that rely on foreign manufacturers.
- Operational Impacts: Facilities should prepare for changes in inspection frequency and protocol, including the possibility of sudden site visits. Conducting mock inspections, reviewing documentation and updating training protocols are recommended.
- Strategic Planning: Companies may wish to evaluate their global supply chains and bolster internal compliance in anticipation of greater scrutiny. In addition, facilities should have a clear plan of response for unannounced FDA inspections.
Conclusion
The FDA is taking steps to recalibrate its foreign inspection program following years of disruption and criticism. The combination of newly announced and previously planned reforms signals an era of heightened regulatory oversight and increased enforcement. Companies operating in or sourcing from overseas markets should proactively assess their compliance posture and supply chain risk management.
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This article is prepared for the general information of interested persons. It is not, and does not attempt to be, comprehensive in nature. Due to the general nature of its content, it should not be regarded as legal advice.
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