FDA CBER Issues Untitled Letters for Violations

Detected March 23rd, 2026

Summary

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.

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What changed

The FDA's Center for Biologics Evaluation and Research (CBER) issues untitled letters as an initial correspondence to regulated entities citing violations of regulations. These violations are deemed not to meet the threshold for a more significant Warning Letter. Untitled letters can arise from reviews of advertising and promotional labeling, inspections under CBER's bioresearch monitoring program, or surveillance of internet websites.

These letters serve as a notice of non-compliance and typically require corrective action from the regulated entity. While not as severe as Warning Letters, they indicate a need for immediate attention to regulatory deficiencies. Companies receiving an untitled letter should review the cited violations and implement necessary changes to ensure compliance with FDA regulations to avoid potential escalation to more serious enforcement actions.

What to do next

Review untitled letters for cited violations
Implement corrective actions to address identified deficiencies
Ensure advertising and promotional labeling complies with FDA regulations

Source document (simplified)

An Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter. Examples when CBER has issued an Untitled Letter include after its review of a manufacturer's advertising and promotional labeling, after an inspection under CBER's bioresearch monitoring program or by Team Biologics, and as a result of internet website surveillance.