FDA Inspections: A Vital Public Safety Net
ORA Takes Concrete Steps to Increase Inspectional Capacity
By Douglas Stearn, J.D., Deputy Associate Commissioner for Regulatory Affairs
Inspections are the cornerstone of U.S. food and drug safety, serving as a critical line of defense against contamination, adulteration, and other hazards lurking in our food and drug supply. By upholding rigorous safety standards, holding stakeholders accountable, and facilitating swift response to threats, FDA inspections, and the people who carry them out, safeguard public health and uphold consumer confidence.
As we navigate an increasingly complex world of manufacturing and distribution, the FDA must continuously modernize and improve how we conduct the inspections that protect the health and well-being of Americans and their families. This means we must not only increase our ability to respond to new and rapidly evolving medical and food technologies and industries, but must also be prepared to oversee a surging number of manufacturing facilities and other types of operations across the country and the world.
The challenge is immense. Last year, our teams, including our consumer safety officers and investigators, worked in over 90 countries scrutinizing the foods, drugs, medical products, cosmetics, and other products relied upon and used by a widely diverse U.S. consumer base. And this FDA geographic presence—our global workplace as we see it—will only expand in the years to come, as will American demand for safe and reliable foods, drugs, and other healthcare products sourced from all corners of the globe.
Strongly committed to our mandate to keep the public safe, in 2024, the Office of Regulatory Affairs (ORA), the lead office for conducting all field work, including inspections, within the FDA, enacted a strategy to dramatically improve the quality and quantity of our inspections to keep pace with global supply realities and consumer demand. Our strategy focuses on our people, operations, partnerships, and how we manage ourselves. ORA believes these steps will better safeguard you and the products you and your family depend upon.
Our People
The FDA mission cannot be fulfilled without its investigators, people highly skilled, technically trained, and prepared to carry out inspections of farms, food and drug manufacturing plants and facilities anywhere in the world. Our recent story featuring a drug investigator who prevented harmful statin drugs from entering the United States reveals the great skill and care involved in this kind of work. And while these men and women have a deep passion for their mission, the job is challenging, particularly when investigators must travel overseas for weeks at a time away from family. Therefore, retaining, training, and recruiting inspection personnel is priority one. A recruitment campaign is underway that will support our current teams by bringing in additional talent, with specialized knowledge in areas such as biotechnology, pharmaceuticals, medical devices, and food safety. Newly hired investigators will be supported through targeted training programs that use in-person, virtual, and hybrid course formats to ensure investigators are highly skilled in implementing regulatory standards and are fluent with emerging technologies in manufacturing processes. Additionally, the FDA will leverage increased salaries, student loan repayment, and targeted training to supervisors and management to further prioritize the retention of those highly trained, professional investigators.
Our Operations
Modernizing and improving inspectional capacity must be data-driven. In 2024, our operations staff crunched extensive data regarding inspectional performance and workforce dynamics to determine where and how we can do better. This focus on operational oversight is helping the FDA understand which inspection functions, processes, timeframes, and key indicators may require more attention and resources. Operations analysis helps us to identify and manage risk and monitor performance data to better target operational improvements that foster a culture of accountability while meeting our inspectional goals.
ORA uses risk management to improve our governance of inspections. Risk management entails putting our most intensive scrutiny on the most vulnerable food, drug, and medical products, for instance, and on firms with a history of noncompliance or lack of safety controls. By systematically identifying and prioritizing high-risk areas at the enterprise-level, leadership can allocate resources towards overcoming these challenges to our inspectional capacity. Improved governance through risk management will ensure clear accountability and streamlined decision-making processes, enabling the agency to adapt swiftly to emerging challenges and evolving regulatory landscapes.
Strategic budgeting also plays a pivotal role in enhancing our operations. By moving ORA’s budgetary decision-making to the program level, each inspectional program will be able to leverage available resources to best recruit and compensate skilled personnel in the way best-suited to meeting their inspectional workload.
Our Partners
Our state, local, territorial, tribal, and international regulatory partners are crucial for keeping the public safe and for helping us grow FDA’s overall capacity for inspectional oversight. Simply put, we couldn’t fulfill our vast public mandate without their support. ORA recently completed a Return on Investment (ROI) analysis for its state partnership agreements, prompting us to implement several improvements to our partnership program management and to enhance communications of our partners’ inspectional accomplishments.
Inspections act as a preventative measure, identifying potential hazards before they escalate into public health crises. By meticulously examining production facilities and processes, investigators can pinpoint areas of concern and enforce corrective actions to mitigate risks. Whether it is ensuring proper sanitation practices, monitoring storage conditions, or verifying ingredient integrity, our investigators and our regulatory partners, here and around the globe, provide the necessary oversight to uphold safety standards.
Moreover, inspections serve as a means of accountability, holding manufacturers, producers and distributors accountable for their practices. By subjecting them to regular scrutiny, inspections create transparency and incentivize compliance with safety regulations. This accountability not only protects consumers from harm but also fosters trust in industry, reassuring the public that their well-being is a top priority. Inspections, where investigators have time for conversations with firm staff about food safety practices and culture, for instance, also builds relationships and fosters industry leaders who care as deeply as we do about the safety of the foods, drugs, and other medical and consumer products in this country.
Critics may argue that inspections place undue burdens on businesses, citing concerns about cost and regulatory compliance. However, the cost of a single illness outbreak far outweighs the investment in preventive measures. The economic and human toll of illness, hospitalization, and loss of productivity underscore the importance of prioritizing public safety through inspections, conducted by skilled and dedicated regulatory professionals.
Upholding common standards also helps to ensure that patients receive quality medical products that address their needs effectively. The measures outlined above fortify the FDA's ability to uphold our rigorous standards of safety and quality across industries under its purview, ultimately safeguarding the well-being of consumers and promoting public confidence in the integrity of regulated products.