FDA Untitled Letters

FDA Advisory Letters Notify Firms of Federal Law Violations

The FDA's Center for Veterinary Medicine is posting Untitled Letters on its website to inform the public about firms violating federal law. These letters notify firms of violations that do not meet the threshold for a Warning Letter but still require correction.

FDA Untitled Letters Issued 2011-2018

The FDA has posted a collection of 83 untitled letters issued between 2011 and 2018 by its Center for Food Safety and Applied Nutrition (CFSAN). These letters address violations related to manufacturing controls or labeling that did not meet the threshold for a Warning Letter.

FDA CBER Issues Untitled Letters for Violations

The FDA's Center for Biologics Evaluation and Research (CBER) issues untitled letters to regulated industries for violations that do not meet the threshold for a Warning Letter. These letters address issues found in advertising and promotional labeling, bioresearch monitoring, and internet surveillance.

FDA Untitled Letters to Pharmaceutical Companies

The FDA's CDER Freedom of Information Office has published a list of 34 untitled letters issued to pharmaceutical companies between February 2026 and September 2025. These letters address promotional communications for various prescription drugs, indicating potential violations of FDA regulations regarding drug advertising and promotion.