Food Facility Initial Registration
All domestic and non-U.S. facilities that manufacture, process, pack, or hold food and dietary supplements for consumption in the U.S. must register with the FDA. This mandatory biannual registration occurs every two years, and the next cycle began October 1 and ends December 31 2024.
MarketReady is here to assist you through the process. We specialize in supporting businesses with their facility registration and can serve as your U.S. agent for foreign facilities. If you miss this window, your registration will not count, potentially leading to an FDA Warning Letter.
Our base price covers typical initial registration for foreign or domestic manufacturers. If you are not registering your facility for the first time, click here.This process ensures you have a FFR and DUNS number. Additional consulting hours are available if your registration requires extra support. Please reach out to our team if you have any questions on the scope of your registration.
If you are a foreign manufacturer, for an additional $250 (per hour), you can add U.S. Agent services, which include assistance with follow-up questions or correspondence from the FDA regarding registration.
If you designate MarketReady as your U.S. Agent, further U.S. Agent services, as needed, will be provided at our standard hourly rate. For foreign facilities, a retainer is required. As your U.S. Agent, we will serve as the primary liaison between your foreign facility and the FDA, ensuring clear and timely communication.
Our role may involve:
- Managing FDA registration on your behalf
- Coordinating foreign inspection activities and logistics
- Addressing regulatory or import-related concerns
- Responding promptly to FDA inquiries
A U.S. Agent plays a critical role in maintaining compliance and ensuring seamless interaction with the FDA for foreign companies.
