The Food and Drug Administration (FDA) protects public health by coordinating, initiating, and/or monitoring regulatory and recall actions, reviewing and managing compliance policies and processes, and evaluating data to assess and enhance agency compliance activities.

The Office of Regulatory Affairs (ORA) within FDA has substantially evolved its product safety and quality model to keep ahead of the possible risks in an ever-changing world of manufacturers and producers. While import growth, rates have accelerated, so too has the need for highly standardized operations within the government and the marketplace. The new global implications have forced FDA to recognize major implications such as pressures to reduce cost, increase productivity and capitalize on quality improvement activities while maintaining strong global safety standards.

The Code of Federal Regulations (CFR) Title 21 Part 7 (21CFR7) governs the practices and procedures applicable to regulatory enforcement actions initiated by the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other laws that it administers. A recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers. A correction is further defined as the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. Any firm may initiate a recall when its product is deemed to be in violation of FDA regulations and laws. Throughout the execution of a recall, it is the FDA’s responsibility to provide guidance to recalling firms, determine the hazard posed by the recalled product, inform the public of potential health risks, and monitor firms’ recall effectiveness, in part, by conducting recall audit checks (RACs) at recalling firm’s consignees to determine whether the consignee received the recall notification and followed instructions in the notification.