FDA has issued draft guidance for FDA staff regarding food facility registration enforcement. For domestic facilities that are not registered, FDA investigators are to educate facility management and, if after education they are not registered, an "untitled letter" may be issued to the food facility by the district office. For foreign facilities, the Center for Food Safety and Applied Nutrition or the Center for Veterinary Medicine, as appropriate, are authorized to issue "untitled letters" if the facility has been advised of the need to register.
Food and Drug Administration
Compliance Policy Guide Sec. 100.250 Food Facility Registration - Human and Animal Food
*The purpose of this document is to provide guidance for FDA staff on food facility registration under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), including the requirement that certain food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and FDA's authority to suspend a food facility's registration.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.