Issuance of Untitled Letters

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<main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Issuance of Untitled Letters</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fissuance-untitled-letters" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Issuance%20of%20Untitled%20Letters&url=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fissuance-untitled-letters" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fissuance-untitled-letters&title=Issuance%20of%20Untitled%20Letters&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Issuance%20of%20Untitled%20Letters&body=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fissuance-untitled-letters" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <h3>Background</h3> <p>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.</p> <p>For more information, see “<a href="/media/71878/download" target>Untitled Letters</a>” in the Regulatory Procedures Manual.</p> <h3>Posting</h3> <p>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.</p> <h2>Center Specific Untitled Letters</h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8fea9b94-e2ec-4ecb-bad1-26b5d1a6f9a5" href="/vaccines-blood-biologics/enforcement-actions-cber/untitled-letters-cber" title="Untitled Letters (CBER)">Center for Biologics Evaluation and Research (CBER)</a></li> <li><a href="/untitled-letters">Center for Food Safety and Nutrition (CFSAN)</a></li> <li><a href="/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters">Center for Drug Evaluation and Research (CDER)</a></li> <li><a href="/medical-devices/industry-medical-devices/letters-industry">Center for Device and Radiological Health (CDRH)</a></li> <li><a href="/animal-veterinary/compliance-enforcement/advisory-action-letters">Center for Veterinary Medicine (CVM)</a></li> </ul>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-02-07T12:35:00Z">02/07/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> </div> </li> </ul> </aside> </div> </section> </aside> <aside 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Issuance of Untitled Letters | FDA