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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Compliance Actions on Biologics Advertising & Promotional Labeling

A Warning Letter is an informal, advisory correspondence, issued to achieve voluntary compliance and to establish prior notice. 

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.


Contact FDA

Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1093 New Hampshire Avenue

WO Building 71

Silver Spring, MD 20993