FDA CBER Issues Untitled Letters for Violations

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.