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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Untitled Letters (CBER)

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.

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Approvals & Clearances

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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