On Oct. 1, 2024, the FDA implemented its restructuring of the Office of Regulatory Affairs (ORA) to form a new Office of Inspections and Investigations (OII), which Commissioner of Food and Drugs Dr. Robert M. Califf said would focus on inspections, investigations and imports as its core mission.

Califf said that the restructuring of ORA — part of the largest reorganization in the agency’s history, with approximately 8,000 FDA staff members affected — “has an impact on how the FDA oversees all FDA-regulated products.”

The new OII, he added, will have “an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission.”

With OII focused on inspections, investigations and imports, other compliance functions that had been managed by ORA are being transferred to the compliance offices within the FDA’s product centers.

The reorganization was the subject of an FDA Statement of Organization, Functions and Delegations of Authority published in the Federal Register on June 3, 2024 (89 Fed. Reg. 47567).

FDA-regulated companies need to understand the sweeping changes in the agency's enforcement structure so that they know how the new processes work — as well as know whom in the FDA they now need to contact as compliance issues arise.

Companies also must be ready for speedier resolutions of alleged violations identified during an FDA inspection — now that the agency's product specialists will be more involved in reviewing the issues and evaluating the corrective actions that a company proposes.