Warning Letter

Warning letters are written communications from FDA, in this case DDMAC, to a company notifying the company that DDMAC considers one or more promotional pieces or practices to be in violation of the law. If the company does not take appropriate and prompt action, as requested in the warning letter, to correct the violation, there may be further enforcement action without further notice.

Warning letters are issued by the DDMAC Division Director and receive concurrence from appropriate officials in the Center for Drug Evaluation and Research. Companies have 15 working days to respond to the warning letter. Warning letters are put on display at the time of issuance in FDA's Freedom of Information office.