FDA FACILITY REGISTRATION
The U.S. Food and Drug Administration (FDA) requires any companies with physical facilities that manufacture, process, pack, or store food, including Dietary Supplements and Animal Food or Pet Supplements to register with the agency; this is the registration of food facilities. Moreover, each registration has a bi-annual requirement to renew. Companies with facilities that do not perform these specific functions are not required to register with FDA; virtual companies that outsource all such work commonly known as an Own Label Marketer (OLM) are not required to register, but such companies are required to qualify their vendors and ensure that each vendor is properly registered with the FDA. When a facility is registered with the FDA, the FDA does not issue any type of certificate nor is a certification required; rather the FDA issues a FACILITY REGISTRATION Identification Number often terms a “Facility Registration ID”, a “FDA Facility ID#”, etc. However, a certificate of FDA registration may be obtained from REJIMUS and provided to other vendors or distribution companies like Amazon or be kept on file.
Companies that want to sell their products through Amazon are often asked to provide a Certificate of FDA Registration of the food facilities. REJIMUS has helped hundreds of small businesses get their registration requirements completed, along with other documentation to ensure all labeling and claims are in line with the applicable regulations and Amazon’s Seller Requirements. We have also help troubleshoot and resolve issues related to the delisting of products from Amazon.
If a certificate of FDA Facility Registration is requested from Amazon, or some other entity for whatever reason, we can provide your company with a certificate along with the actual registration for each facility (only as required) for $300 USD for the first time registrations and $225 once every two years for standard renewals provided your operations remain the same. REJIMUS only can generate a certificate of FDA registration with each valid FDA registration done by REJIMUS, and not any other third-party. For companies with food facilities out of the United States, our registration of each facility comes with being your dedicated U.S. Agent for the FDA in support of compliance matters and import support for your food products into the U.S. REJIMUS provides support for importing, including USDA import permit registrations and management, for your imported goods including Prior Import Notifications.
Get your food facilities registered with the FDA and your FDA Registration Certificate today! $300 for first-time registrations and $225 USD per facility for standard renewals (only once every two years). For inquiries regarding FDA registration support, please fill out the contact form below, email us at firstname.lastname@example.org, or complete the FDA Facility Registration Form to get started.