Food Facility Registration U.S. Agent Services (Hourly)
All domestic and non-U.S. facilities involved in manufacturing, processing, packing, or holding food, ingredients, and dietary supplements for consumption in the United States are required to register with the FDA. This registration is mandatory for all new facilities and must be renewed every two years as part of a biannual process. The FDA uses this registration to ensure updated information is provided to facilitate communication, support regulatory compliance, public health and safety. FFR provides FDA with current information to facilitate inspections, recalls, outbreak or trackback investigations, to increase transparency, and to promote accountability in the supply chain.
We can also serve as your U.S. Agent for international facilities, making process smoother for non-U.S. businesses. A US agent can facilitate communications with the FDA regarding registrations, importation, or inspection. Additionally, we can help support compliance with US regulations for imported goods regulated under the Food Safety Modernization Act (FSMA).
MarketReady offers US Agent services to assist with any follow-up questions or correspondence from the FDA regarding your facility registration. A U.S. Agent plays a critical role in maintaining compliance and ensuring seamless interaction with the FDA for international companies. By designating MarketReady as your U.S. Agent, we will serve as the primary liaison between your international facility and the FDA, ensuring clear and timely communication. The cost of $945 would cover MarketReady serving as your U.S. Agent, including the initial registration process. For international facilities, if/when ongoing FDA interactions are anticipated, a retainer is required. This will ensure effective, uninterrupted support and effective communications with the FDA. This retainer ensures that you have reliable and timely assistance as needed throughout the registration process and beyond. It's crucial to meet the biannual registration deadline.
Potential regulatory consequences include an FDA Warning Letter and other sanctions. MarketReady ensures that your facility remains in good standing with the FDA, helping you avoid costly compliance setbacks. Our base price of $695 covers typical initial registration for international or domestic manufacturers. This process ensures you have an initial FDA FFR and DUNS number. If your FDA facility registration requires additional support, consulting hours are available to assist with any complexities. Need only a U.S. Agent to be your liaison during the registration process, MarketReady is here to help. Our role may involve:
- Managing FDA registration on your behalf
- Coordinating international inspection activities and logistics
- Addressing regulatory or import-related concerns
- Responding promptly to FDA inquiries
MarketReady's team is ready to help you navigate the process. Reach out to us for any questions or concerns you may have and determine the additional consulting hours needed. We’ll ensure you receive the guidance needed for a smooth and compliant registration.
