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Warning and Untitled Letters - Background

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Transparency Report Arrow Background

Summary of Public Comments

Considerations

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Warning and Untitled Letters

1. Background
In the event of a violation of the Federal Food, Drug, and Cosmetic Act, depending on its nature, FDA may give individuals and firms an opportunity to take voluntary and prompt action to correct the violation before FDA initiates an enforcement action.1 FDA will issue either a warning letter or an untitled letter to individuals or firms notifying them of such violations to allow them to voluntarily comply with the law.
Warning letters are used for violations that may lead to enforcement action if not promptly and adequately corrected. Untitled letters are used for violations that do not meet the threshold of regulatory significance for a warning letter and request correction of the violations. Unlike a warning letter, an untitled letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action.
FDA generally is under no legal obligation to warn individuals or firms about violations before taking enforcement action.
FDA currently posts warning letters on the FDA Web site and if FDA can determine that a firm has fully corrected violations raised in a warning letter, FDA will issue an official “close-out” notice that also will be posted online. If requested by a recipient of a warning letter, FDA will post the company or individual’s response to the warning letter on the FDA Web site. Some Centers proactively post untitled letters, for example, the Center for Biologics Evaluation and Research (CBER) and the Division of Drug Marketing, Advertising, and Communications (DDMAC) in the Center for Drug Evaluation and Research (CDER).