FDA Voices
Investing in FDA’s Inspectional Enterprise
Strengthening Our Operations and Workforce to Advance Public Trust
By: Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations and Lowell Zeta, JD, Acting Chief of Staff and Deputy Commissioner for Strategic Initiatives
At the U.S. Food and Drug Administration, transparency with our stakeholders is essential to our mission. Patients, healthcare providers, and industry rely on a regulatory system that is rigorous, but also predictable, understandable, and accountable.
As part of the FDA’s broader transparency efforts, we are taking steps to modernize how we communicate, how we make decisions, and how we carry out regulatory responsibilities. A critical component of that effort is the transformation of our inspectional enterprise, including how we plan, coordinate, and execute inspections across the agency.
We are advancing that transformation through a more aligned, risk-informed, and transparent approach to inspectional operations that is already taking shape across the FDA.
Central to this work is a commitment to the people who make the FDA’s inspectional mission possible. By investing in our workforce — through training, career development, cross-functional opportunities, and organizational transparency — we are building an agency that attracts, retains, and empowers the talent necessary to fulfill our public health and public safety obligations for the long term.
An Evolving Landscape Requires a New Approach
As the FDA celebrates its 120th milestone anniversary, we reflect on how the agency’s field operations have changed. Since the nineteenth century, federal regulators sought to protect Americans from adulterated and misbranded products.
The FDA’s inspectional responsibilities have grown more complex over time. Global supply chains span dozens of countries. Manufacturing technologies continue to evolve. Data integrity expectations are increasing, particularly for facilities that rely heavily on electronic systems and distributed operations.
At the same time, the FDA continues to uphold robust oversight of an increasing number of regulated facilities while managing finite inspectional resources. Recognizing that traditional inspection models and increasing travel demands can limit annual inspection capacity and that workforce sustainability is inseparable from mission effectiveness, the FDA is pursuing approaches that enhance surveillance and better support the investigators who carry out this critical work while avoiding gaps in surveillance coverage.
To address these challenges the agency is pursuing the opportunity to better align at the enterprise level.
The scale of this work is significant. In FY 2025 alone, the FDA conducted more than 17,000 domestic and international inspections of FDA-regulated products, reviewed nearly 75 million import lines, and collected more than 25,000 samples — underscoring both the breadth of our oversight responsibilities and the imperative to deploy inspectional resources with precision and strategic intent.
Establishing the Inspectional Affairs Council (IAC)
The FDA recently established the Inspectional Affairs Council, or IAC, as a cross-agency governance body focused on inspectional matters.
The IAC brings together leadership from across the FDA, including each of the Centers, the Human Foods Program, the Office of the Chief Scientist (OCS), the Office of Global Policy and Strategy (OGPS), the Office of Operations, the Office of the Chief Counsel, and the Office of Inspections and Investigations (OII). It is co-chaired by the Deputy Commissioner for Strategic Initiatives (DSCI) and the Associate Commissioner for Inspections and Investigations (ACII). This structure ensures an enterprise-wide perspective and operational accountability while facilitating appropriate standardization and the effective allocation of resources.
The purpose of the IAC is straightforward. It coordinates strategic decision-making and enhances alignment between OII and the Centers on inspectional activities. It provides a forum to modernize operations, strengthen workforce strategy, and streamline processes that directly affect the FDA’s ability to oversee regulated products.
In addition, the IAC - Staff Manual Guide (SMG), which issued in May 2026, ensures that these processes are formalized, consistently applied, and visible to internal and external partners. This identifies obligations and provides the framework that promotes consistency, accountability, and effective management of inspectorate resources across the agency.
Inspectional Enterprise Calibration
Right-sizing means aligning inspectional effort with risk, complexity, and public health need. It recognizes that a facility with stable operations and documented voluntary compliance history may justify a lower inspectional priority relative to a facility with complex manufacturing processes, novel technologies, or known compliance concerns.
To implement this, OII, the Centers, and OGPS, which houses investigators stationed in the foreign offices, are developing operating agreements that define responsibilities in specific terms. For example, Centers are responsible for establishing inspectional priorities and providing technical expertise tied to product risk and regulatory requirements. OII maintains responsibility for field execution, evidence collection, and operational planning. These roles are coordinated through shared planning cycles, including annual work planning and periodic reassessment of resource allocation.
The agreements also address practical elements such as evaluating the inspection cadence/frequency needed, how laboratory resources are aligned with inspectional work and how state regulatory partners are integrated into the overall inspection strategy, for example. The aim of these agreements is simple: streamline inspectional assignments, standardize priorities, establish functional responsibilities, and define expected timelines for execution and reporting.
Modernizing Inspectional Approaches
Alongside governance and process improvements, the FDA is advancing more modern inspectional approaches that reflect today’s risk environment. We continue to consider and explore the use of new and already existing inspectional tools to ensure maximized inspectional capacity and oversight.
Alternative tools include — but are not limited to — records requests under statutory authority, remote interactive evaluations, and the use of inspection reports from trusted regulatory partners under mutual recognition agreements. These tools allow the FDA to gather high-quality information without always needing to conduct a full on-site inspection, which helps allocate resources more effectively.
A key pillar of this modernization effort is continuing to establish parity in our inspectional posture between domestic and foreign facilities. Placing foreign and domestic facilities on a more level playing field is not only a matter of consistency in operations — it is a public health imperative, given the extent to which Americans depend on globally sourced products.
The FDA is also intensifying its use of unannounced foreign inspections as a more effective tool for assessing true manufacturing quality, particularly in countries on which the United States relies for critical drug supplies. In India, the FDA’s foreign office went from 47% unannounced inspections in FY 2025 (139 total inspections) to 87% unannounced in FY 2026 year-to-date (76 total inspections). For the China Office, the share of unannounced inspections rose from 19% in FY 2025 (192 total inspections) to 61% in FY 2026 year-to-date (114 total inspections). These shifts represent a meaningful change in how the FDA assesses and verifies compliance at high-priority foreign manufacturing sites.
Strengthening Workforce and Operational Readiness
Modernizing inspectional work critically depends on a highly trained and adaptable workforce. The next-generation OII workforce model is not a move to generalists — far from it; it has been carefully designed to deepen talent by expanding investigators’ capabilities, strengthening specialized expertise, and creating better career pathways that support mobility and retention across the FDA.
Indeed, specialized training has long been central to the FDA's inspectional model — and with good reason. Cultivating deep technical expertise among investigators is foundational to effective oversight. Having rigorously trained inspectors in the field is not a procedural formality; it is a direct expression of our agency’s core public health and public safety mission. Ensuring our investigators have the skills and knowledge to assess complex manufacturing operations, identify compliance failures, and protect the public is among the most consequential investments the FDA makes.
The FDA is strengthening investigator training and readiness through expanded partnerships, including with federal training programs, to accelerate the time from hiring to full field certification. This includes more structured onboarding, standardized training modules, and cross-functional development opportunities to ensure investigators can operate effectively across different product areas when needed.
The FDA’s current approach reflects a more deliberate and human-centered workforce strategy — one consistent with the practices of the highest-performing regulatory and industry organizations. We are thoughtful about how we invest in training, how we design career pathways, and how we create cross-functional opportunities that optimize agency resources while improving retention. By considering work-life sustainability and long-term career planning, the FDA is working to build an inspectorate that is not only technically excellent, but also resilient, engaged, and positioned to grow with the agency.
What This Means for Stakeholders and Looking Ahead
The work of modernizing the FDA’s inspectional enterprise is ongoing. For industry, more consistent processes support better planning and more efficient interactions with the agency.
For patients and consumers, a risk-based and right-sized inspectional system strengthens the FDA’s ability to focus on the most significant risks while maintaining broad oversight across the regulated landscape.
For the FDA, these changes improve how we use our resources, how we coordinate across programs, and how we deliver on our public health mission.
Through the IAC and related OII modernization initiatives, the FDA is building an inspectional enterprise that is aligned across programs, grounded in risk-based decision-making, and transparent by design. This work strengthens public trust and ensures that the FDA continues to meet the demands of a complex and rapidly evolving public health landscape.