Depending on the nature of the violation, it is the FDA’s practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action.
Advisory action letters include Untitled and Warning Letters. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. Warning Letters are issued for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Warning Letters are posted on FDA’s website.
An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter. However, Untitled Letters serve as an initial notification to firms that FDA is aware of their violations of federal law. It often serves to document formal notification by FDA to the person or firm, and allows the firm to come into compliance without further FDA action.
The Center for Veterinary Medicine (CVM) is posting Untitled Letters on its website to keep the public informed about persons or firms violating the law. We expect that posting these letters will deter other similar violations.