FDA Advisory Letters Notify Firms of Federal Law Violations

FDA Untitled Letters

Published May 1st, 2023

Detected March 23rd, 2026

Summary

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.

View original document View source feed page

What changed

The FDA's Center for Veterinary Medicine (CVM) has begun posting Untitled Letters on its website. These letters are issued to individuals and firms for violations of the Federal Food, Drug and Cosmetic Act that do not meet the regulatory significance threshold for a Warning Letter. The CVM aims to keep the public informed about these violations and provide firms an opportunity to make prompt, voluntary corrections.

While Untitled Letters do not carry the same weight as Warning Letters, they serve as formal notification of violations and document FDA's awareness of non-compliance. Firms receiving an Untitled Letter should review the cited violations and take necessary corrective actions to come into compliance and avoid potential further FDA enforcement. The posting of these letters on the CVM website increases transparency regarding regulatory compliance within the animal health industry.

What to do next

Review CVM Untitled Letters posted on the FDA website
Assess cited violations for potential non-compliance
Implement corrective actions as necessary to ensure compliance with federal law

Source document (simplified)

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.