FDA Organization and Inspection System

The U.S. Food and Drug Administration (FDA) is a federal government agency positioned under the U.S. Department of Health and Human Services (HHS), responsible for regulating food, pharmaceuticals, and other products. Following the organizational restructuring that took place in 2024, its organizational structure has been significantly updated. Below is a detailed description of FDA’s latest organizational structure and inspection system.

1. FDA Headquarters and Location

FDA headquarters is located at the White Oak Federal Research Center campus in Silver Spring, Maryland. This facility serves as a comprehensive complex equipped with state-of-the-art research facilities and administrative functions, enabling close coordination with central federal government operations. Due to its proximity to Washington, D.C., it is commonly stated that “FDA is in Washington,” but the precise location is in Maryland.

The White Oak campus consolidates most of FDA’s headquarters operations and provides a centralized hub for policy development, scientific research, and regulatory decision-making. This strategic location facilitates collaboration with other federal agencies and allows FDA leadership to maintain close ties with Congress and the executive branch.

2. Major Center Composition of FDA

Following the organizational restructuring in 2024, FDA currently comprises several major centers and offices. Each center is responsible for regulation and oversight in specific product areas. The key product centers include:

Center for Drug Evaluation and Research (CDER) is responsible for the evaluation and regulation of human drugs. Operating with eight divisions, it encompasses offices such as the New Drug Review Division, Generic Drug Division, and Strategic Program Division. CDER evaluates the safety and efficacy of prescription drugs, over-the-counter drugs, and generic drugs, and also conducts post-market surveillance. CDER processes more than 100 new drug applications and thousands of generic drug applications annually, making it one of the busiest regulatory bodies in the world for pharmaceutical oversight.

Center for Biologics Evaluation and Research (CBER) is responsible for the evaluation and research of biological products. It oversees biological products including vaccines, blood products, allergenic products, cellular and tissue products, and gene therapy products. CBER plays a particularly important role in establishing regulatory frameworks for emerging biological products. The center has been instrumental in expediting review processes for critical therapies, including those developed during public health emergencies.

Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices and radiological equipment. It evaluates the safety and efficacy of a wide range of medical devices, from simple medical instruments to advanced electronic medical equipment. CDRH also regulates radiation-emitting devices. The center classifies medical devices into three classes based on risk level and applies appropriate regulatory pathways, including the 510(k) premarket notification, Premarket Approval (PMA), and De Novo classification.

The food safety division has undergone significant transformation with the 2024 organizational restructuring. The Human Foods Program was established as a unified organization to streamline food safety oversight. While the Center for Food Safety and Applied Nutrition (CFSAN) continues to exist and maintains its scientific and regulatory expertise, it now operates within a more integrated framework that includes enhanced coordination mechanisms for food safety policy and enforcement. This restructuring was designed to improve efficiency in addressing complex food safety challenges, including those posed by emerging food technologies and the increasingly globalized food supply chain. The Human Foods Program encompasses not only CFSAN’s traditional functions but also incorporates elements of field operations previously managed separately, creating a more cohesive approach to protecting public health from foodborne hazards.

Center for Tobacco Products (CTP) was established following the enactment of the Family Smoking Prevention and Tobacco Control Act in 2009. It is responsible for regulating the manufacture, sale, and distribution of tobacco products, with particular emphasis on preventing youth smoking. CTP also regulates electronic nicotine delivery systems (ENDS), including e-cigarettes, and evaluates premarket tobacco product applications to ensure new tobacco products meet public health standards.

Additionally, the Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), Oncology Center of Excellence (OCE), and various operational offices each play important roles in their respective specialized areas. CVM regulates animal drugs, feeds, and devices, while NCTR conducts research to support FDA’s regulatory mission. OCE, established in 2017, works across FDA centers to accelerate oncology product development and optimize cancer treatment approaches.

3. Field Operations and Inspection System

The FDA’s field operations and inspection system underwent modernization as part of the 2024 organizational changes, though the fundamental structure of the Office of Regulatory Affairs (ORA) has been maintained and strengthened. ORA continues to serve as FDA’s lead office for all field activities, enforcement, and compliance operations, functioning as the eyes, ears, and boots on the ground for the agency.

ORA maintains field offices across the United States, strategically positioned to cover all regions of the country. These field offices function similarly to Japan’s prefectural pharmaceutical affairs divisions, with investigators stationed to conduct inspections and enforcement activities. The field structure includes district offices and resident posts that provide local presence and rapid response capability for regulatory issues.

While inspection decisions are made at FDA headquarters through coordination between the relevant product centers and ORA leadership, the actual inspections are executed by ORA investigators. These highly trained professionals conduct domestic and foreign inspections of facilities that manufacture, process, pack, or hold FDA-regulated products. ORA possesses worldwide inspection authority and conducts international regulatory enforcement activities, reflecting the global nature of modern supply chains.

ORA also stations personnel at ports of entry where they work closely with U.S. Customs and Border Protection to conduct sampling and examination of imported products. This import surveillance function is critical for protecting American consumers from substandard or unsafe products entering from abroad. In fiscal year 2024, FDA processed millions of import entries, demonstrating the massive scale of this operation.

The organizational evolution has resulted in enhanced coordination mechanisms between headquarters and field operations. Key functional areas within the modern field operations structure include:

Biologics and Research Surveillance: This specialized function focuses on oversight of biological product manufacturing and research facilities, ensuring compliance with Current Good Manufacturing Practice (CGMP) regulations specific to biologics.

Medical Device and Radiological Health Surveillance: This division conducts inspections of medical device manufacturers and facilities that use radiation-emitting equipment, verifying adherence to Quality System Regulations (QSR) and radiological safety standards.

Import Operations and Strategy: This function coordinates the comprehensive import surveillance program, working at ports of entry to prevent unsafe products from entering U.S. commerce while facilitating legitimate trade.

These functional areas work in close coordination with product centers to ensure that inspection findings inform regulatory policy and that policy changes are effectively implemented in the field.

4. Compliance Office Functions and Authority

Each FDA center has an Office of Compliance that plays a central role in monitoring and overseeing regulatory compliance. These offices perform critical functions in ensuring that regulated industry maintains adherence to applicable laws and regulations.

One of the most important tools used by Compliance Offices is the Site Selection Model (SSM), a risk-based analytical framework that prioritizes inspection resources. The SSM integrates multiple data sources to assess facility risk profiles, including compliance history, product type, manufacturing complexity, and time since last inspection. This model helps FDA allocate its limited inspection resources to facilities that pose the greatest potential risk to public health. The model is continuously refined based on inspection outcomes and emerging risk factors, making it a dynamic tool for regulatory oversight.

Compliance Offices are responsible for receiving and evaluating Establishment Inspection Reports (EIRs) submitted by investigators following facility inspections. The EIR is a comprehensive document that details the inspection scope, observations, and evidence collected during the inspection. Compliance officers review these reports to determine whether regulatory action is warranted.

Form FDA 483 is issued by investigators at the inspection site and lists conditions that, in the investigator’s judgment, may constitute violations of the Food, Drug, and Cosmetic Act and related regulations. This document represents the investigators’ observations and is provided to facility management at the conclusion of the inspection, allowing for immediate awareness of deficiencies. Firms are expected to respond to Form 483 observations with corrective and preventive actions.

Warning Letters are issued by each center’s Compliance Office, not by field investigators. These formal enforcement documents inform companies and individuals that FDA has determined they are violating the law. Warning Letters clearly describe the violations and advise what must be done to come into compliance. They also indicate that failure to promptly correct the violations may result in enforcement action such as seizure, injunction, or civil monetary penalties. Before issuing a Warning Letter, the Compliance Office conducts a thorough review of the inspection findings, the firm’s response, and relevant regulatory requirements.

Beyond Warning Letters, Compliance Offices have access to a range of enforcement tools matched to the severity and nature of violations. These include:

Untitled Letters: Less severe than Warning Letters, these address violations that do not meet the threshold for Warning Letter issuance but still require correction.

Import Alerts: These administrative actions allow FDA to detain imported products from specific firms or countries without physical examination when evidence suggests systemic compliance problems.

Consent Decrees: In serious cases, FDA may seek court orders requiring firms to take specific actions to correct violations.

Seizures and Injunctions: FDA can request courts to seize violative products or enjoin firms from continuing violations.

Civil Money Penalties: For certain violations, FDA has authority to impose monetary penalties without court action.

The Compliance Offices also coordinate with FDA’s Office of Criminal Investigations (OCI) when violations appear to be intentional or fraudulent, potentially warranting criminal prosecution.

In the modern regulatory environment, Compliance Offices increasingly emphasize voluntary compliance through education and guidance, while maintaining robust enforcement capabilities for serious or persistent violations. This balanced approach recognizes that most firms want to comply with the law but may need assistance understanding complex regulatory requirements.

5. International Inspection and Cooperation

FDA’s inspection system extends far beyond U.S. borders. As pharmaceutical and food supply chains have become increasingly global, FDA has dramatically expanded its international inspection activities. The agency conducts hundreds of foreign inspections annually in countries across Europe, Asia, Latin America, and other regions.

To enhance efficiency of foreign inspections and reduce duplication, FDA has developed mutual recognition agreements and other collaborative arrangements with regulatory counterparts in other countries. For example, FDA has mutual recognition agreements with the European Union and other jurisdictions that allow reliance on inspections conducted by foreign regulatory authorities when they demonstrate comparable inspection standards. These agreements enable FDA to leverage international regulatory resources while maintaining appropriate oversight of products entering the U.S. market.

FDA has also established foreign offices in strategic locations including China, India, Europe, Latin America, and the Middle East. These offices facilitate communication with foreign governments and manufacturers, provide advance notice of inspections, and assist in coordinating international regulatory activities.

6. Inspection Process and Types

FDA conducts several types of inspections based on purpose and regulatory requirements:

Pre-approval Inspections: Conducted before approving new drug applications, biologics license applications, or device premarket approvals to verify that facilities and manufacturing processes meet required standards.

Surveillance Inspections: Routine inspections to ensure ongoing compliance with CGMP and other requirements. The frequency is determined by risk-based models including the SSM.

For-Cause Inspections: Triggered by specific concerns such as adverse event reports, product quality problems, or complaints.

Foreign Inspections: FDA inspects foreign facilities that manufacture products destined for the U.S. market, applying the same standards used for domestic facilities.

During inspections, FDA investigators examine facilities, equipment, processes, records, and finished products. They may collect samples for laboratory analysis and review documentation to verify compliance with regulatory requirements. Inspections are conducted according to standardized procedures outlined in FDA’s Investigations Operations Manual (IOM), ensuring consistency across all inspection activities.

7. Quality Management Systems and Modern Approaches

FDA has evolved from purely compliance-based oversight to emphasizing quality management systems and quality culture. This modern approach recognizes that sustainable compliance requires organizations to embed quality into their operations rather than simply checking regulatory boxes.

The agency encourages pharmaceutical and device manufacturers to adopt comprehensive quality management systems based on International Council for Harmonisation (ICH) guidelines and International Organization for Standardization (ISO) standards. FDA’s guidance documents increasingly emphasize process understanding, risk management, and continuous improvement rather than prescriptive requirements.

This risk-based, modern quality approach aligns with international regulatory trends and has been incorporated into recent guidance documents such as those addressing pharmaceutical quality, manufacturing science, and process validation. FDA expects firms to use quality metrics, identify trends, implement preventive actions, and foster a culture where quality is a shared responsibility across the organization.

Conclusion

The FDA’s organizational structure and inspection system represent a sophisticated regulatory framework designed to protect public health in an increasingly complex global environment. The 2024 organizational changes have enhanced coordination, improved efficiency, and positioned FDA to address emerging challenges in food safety, pharmaceutical innovation, medical device technology, and public health threats.

The field operations and compliance functions work seamlessly with product centers to ensure that regulatory requirements are not only established but effectively enforced. Through risk-based approaches, international cooperation, and emphasis on quality systems, FDA maintains its position as a world-leading regulatory authority while adapting to the evolving landscape of regulated products and global commerce.

Understanding FDA’s structure and inspection processes is essential for companies subject to FDA regulation, as it enables them to better navigate regulatory requirements, prepare for inspections, and maintain the high standards necessary to protect patient and consumer safety. As FDA continues to evolve, staying informed about organizational changes and regulatory expectations remains critical for all stakeholders in FDA-regulated industries.