Which FDA office is the largest and handles inspection and enforcement?

• A. Center for Drug Evaluation and Research
• B. FDA Office of Chief Counsel
• C. FDA Office of Regulatory Affairs
• D. Office of the Commissioner

Answer: (C)

The focus here is which FDA component handles on-the-ground inspections and enforcement actions. The Office of Regulatory Affairs is the FDA’s field arm and the largest office, responsible for inspecting facilities that manufacture, process, store, or distribute FDA-regulated products (drugs, foods, devices, cosmetics, biologics, and more), conducting investigations, and carrying out enforcement activities. This includes unannounced and announced inspections, documenting findings, issuing 483s, and coordinating recalls, seizures, and other enforcement actions. It also oversees import inspections at points of entry and supports surveillance and compliance across the agency.

The Center for Drug Evaluation and Research primarily handles scientific review and regulation of drugs, not day-to-day inspections. The Office of Chief Counsel provides legal services, not routine inspections, and the Office of the Commissioner sets policy and overall leadership, not the inspection program.