Many of you will have already received a reminder from FDA to renew your food facility registration before December 31, 2026. This biennial registration is required of all facilities that manufacture, process, pack, or hold (warehouse) foods, dietary supplements, pet foods and/or the ingredients used in such products that are intended for the U.S. market. Registration is required for all facilities whether located in or outside of the U.S. The only difference is that non-U.S. facilities must name a U.S. Agent who is based in the U.S. on their registration form.
Food facility registration is required as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and was effective December 12, 2003. The registration is free and we encourage you to do it yourself rather than paying anyone to retype information only the you have. Note that FDA does not provide a certificate of registration and that registration does not indicate that registered facilities comply with all applicable FDA regulations. Also note, that although we at FDA Compliance Simplified encourage companies to handle their own registration my company can help with questions regarding your registration.
If you have not registered your facility previously, you will need a Unique Facility Identifier (UFI). FDA accepts Data Universal Numbering System (DUNS) numbers. Getting a DUNS number is also free. Other information required for registration includes the company name, trade name, address, contact information, the type of products handled at the facility. Importantly, part of the registration process is acknowledging that FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug and Cosmetics Act.
Here are some links to help you comply with this requirement:
Facility registration is not difficult. It is, however, difficult to fathom that the year is hurtling toward its end. Contact us regarding those end of year projects you’ve been meaning to get to!
