Food Facility Registration Assistance
Masuu US Agent offers extensive support to pharmaceutical and food companies in the registration and renewal of their Food Facility Registration (FFR) with the USFDA. As outlined in 21 CFR 1.230-1.245, the Food Facility Registration (FFR) is a mandatory requirement for any facility involved in the manufacturing, processing, packing, or storing of food, beverages, or dietary supplements that are intended for commercialization or consumption by individuals in the United States. This registration must be completed prior to importing products into the United States.
Masuu US Agent assists both domestic and foreign companies in registering their facilities with the FDA. For domestic facilities, it is mandatory to appoint a US Agent. Masuu US Agent will serve as the bridge between the pharmaceutical or food company and the FDA, facilitating all communication and interaction with the agency. The entire facility registration process will be carried out using the FDA’s Food Facility Registration Module (FFRM) through the Food Facility Registration and Listing System (FURLS).
The Food Facility Registration (FFR) is exclusively intended for FDA use and serves as a registry of facilities operating within the United States. Only the facilities that have submitted their registration information will be listed in the FFRM portal. The system does not maintain a separate database specifically for FFR registrations.
Masuu US Agent offers a full suite of services for companies seeking to register, update, or renew their Food Facility Registration (FFR) with the FDA, in accordance with 21 CFR 1.230-1.245. We assist with the entire process to ensure that companies stay compliant with FDA regulations and that their facilities are properly registered in the FDA’s database.
Certain categories of food products are required to register their facilities with the FDA. Examples include:- Alcoholic Beverages (21 CFR 170.3 (N) (2))
- Baby (Infant and Junior) Food Products, including infant formula
- Bakery Products, such as dough mixes and icings (21 CFR 170.3 (N) (1), (9))
- Beverage Bases (21 CFR 170.3 (N) (3), (35))
- Candy Without Chocolate, Candy Specialties, and Chewing Gum (21 CFR 170.3 (N) (6), (9), (25), (38))
- Cereal Preparations, including breakfast foods and instant cereals (21 CFR 170.3 (N) (4))
- Cheese and Cheese Product Categories (21 CFR 170.3 (N) (5))
- Dietary Supplement Categories
The Food Facility Registration must be renewed every two years between October 1 and December 31 to ensure it remains active and in compliance. Masuu US Agent takes care of all aspects of the registration process, including the preparation and submission of required documentation and the handling of any queries from the USFDA.
With expert guidance and comprehensive support, Masuu US Agent helps companies navigate the complexities of regulatory requirements. We ensure that your facilities remain fully compliant, accurately registered, and properly listed in the FDA database, enabling smooth operations and avoiding regulatory setbacks.