Advisory Action Letters
When there is a violation of the Federal Food, Drug and Cosmetic Act, the FDA may, depending on the nature of the violation, give individuals and firms an opportunity to make voluntary and prompt corrections by taking an advisory action.
Advisory actions 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 other enforcement action, such as an injunction, if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with 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, and they document formal notification by FDA to the person or firm. They also allow 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.
Untitled Letters
Warning Letters
Additional Resources