Inspections, Compliance, Enforcement, and Criminal Investigations

Issuance of Untitled Letters

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. Untitled letters are used for violations that may 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.

For more information, see “Untitled Letters” in the Regulatory Procedures Manual.

Posting

FDA generally posts an Untitled Letter to a Center website on FDA.gov when the Center has determined posting would fulfill one or more of the following objectives:  (1) respond to 3 or more received or anticipated requests for the letter under the Freedom of Information Act (FOIA);  (2) inform the public about violative practices and conditions that may pose a risk to their health; (3) deter future violations and allow similarly situated regulated entities to determine what activities and practices FDA finds violative and use the information to increase compliance with the law. This policy does not preclude Center offices from electing to proactively post all untitled letters within a particular program area.  Where FDA adopts an approach to posting untitled letters in a particular program area, the posting will be done as soon as possible, but normally no later than 10 workdays after the letter has been issued.

Page Last Updated: 07/19/2016
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