Proposed Office of Inspections and Investigations (OII) Organization Chart 1

(Updated Dec. 6, 2023)

Office of 

Management

Office of 

Business Informatics 

and Solutions 

Management

Associate Commissioner for 

Inspections and Investigations

Office of

Medical Devices 

and Radiological 

Health Inspectorate

Office of

Human and Animal 

Drug Inspectorate

Office of

Biologics 

Inspectorate

Office of

Bioresearch

Monitoring 

Inspectorate

Office of

Human Food

 Inspectorate**

Office of 

Criminal 

Investigations

Office of 

Import Operations

Department of Health and Human Services

Food and Drug Administration

Office of Inspections and Investigations

Office of

Animal Food 

Inspectorate

Office of 

Field Operations 

and Response*

Proposed Organization Chart for Office of Inspections and Investigations

(Updated Dec. 6, 2023)

Office of

Training, Education 

and Development

Commissioner of

Food and Drugs

*Includes Division of Tobacco Inspectorate

**Includes specialized teams for products such as infant formula

The Associate Commissioner for Inspections and Investigations (ACII) will report directly to the FDA 

Commissioner with responsibility of overseeing the agency’s field operations who carry out inspections, 

investigations, and import operations in support of the FDA’s product centers and programs. The ACII will 

work closely with other FDA executives to ensure priorities are appropriately coordinated and advanced.

Proposed Office of Inspections and 

Investigations (OII) Organization Chart

Descriptions of proposed OII offices:

Commodity Inspection Functions: Aligning inspection resources with center 

and program priorities

•	 The Inspectorate Offices will carry out inspections and other field activities for their individual 

portfolios: Bioresearch Monitoring; Biologics; Medical Devices and Radiological Health; Human 

and Animal Drugs; Animal Food; and Human Food. (Tobacco will be managed under the Office 

of Field Operations and Response.)

Note: The proposed changes reflected here are not approved and will not be implemented until all required reorganization steps have been met.
Proposed Office of Inspections and Investigations (OII) Organization Chart 2

(Updated Dec. 6, 2023)

Cross-Cutting Functions: Executing specialized operations across the 

FDA’s portfolio

•	 The Office of Criminal Investigations will carry out criminal investigation activities for FDAregulated products.

•	 The Office of Field Operations and Response will provide enterprise inspectorate support, 

including leading organizational quality efforts. A Division of Tobacco Inspectorate will 

conduct tobacco inspectional work. An Office of Emergency Response will coordinate the 

agency’s response to emergencies and natural disasters involving FDA-regulated products 

and/or FDA facilities. An Office of Field Regulatory Operations will carry out a variety of 

investigational activities not included in the commodity inspection functions, as well as lead 

inspectorate policy development and review coordination, direct health fraud inspectorate 

activities, and provide consultation on inspectorate recall efforts of FDA-regulated products. 

•	 The Office of Imports Operations will carry out FDA’s field import responsibilities.

Business Management Functions: Delivering the best value in service of the 

public health mission

•	 The Office of Training, Education and Development will coordinate training, education and 

other professional development for OII personnel and partners.

•	 The Office of Management will coordinate budget, travel, facilities and workforce 

management activities across OII.

•	 The Office of Business Informatics and Solutions Management, in partnership with the 

FDA’s Office of Digital Transformation and proposed Office of Enterprise Transformation, will 

coordinate information system and technology management activities across OII.

Note: The proposed changes reflected here are not approved and will not be implemented until all required reorganization steps have been met.