Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.
Facilities that are exempt are:
- Farms
- Restaurants
- Retail Food Establishments e.g. grocery stores
- Nonprofit Food Establishments
- Fishing Vessels
- Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
- Private residence of individuals
- Post Offices, Freight Forwarders
While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.
In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.
Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.
Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: June 06, 2019
Hello, I import food supplements from abroad, store them in my home and then sell over the internet. Do I need registration?
FDA does not consider a private residence as a facility. So a home based food business is exempt from the requirement of FDA registration.
Thank you Namrata for your response. What if my customers ask for my FDA certificate. Can i get one if needed? What is the fee to obtain FDA registration?
No, you can not obtain an FDA registration or FDA certificate. You can tell your customers the same. In future, if you rent/own a facility where you store these products before selling them, you can obtain registration then for that facility.
What are the requirements for UFI?
Starting Oct 01, 2020, facilities will be required to enter a UFI (Unique Facility Identifier) to their food facility registrations. For now, FDA has only recognized DUNS number issued by Dun & Bradstreet as an acceptable UFI. A DUNS number can be obtained free of charge.
Does your company provides assistance with DUNS number application? If so, how much does is it cost?
LMG can guide you through the DUNS application but we do not apply it for you. There is no guidance fee.
I own a commercial kitchen and want to know whether I need to register with FDA?
You will need to register with FDA if your facility is used to manufacture food products for consumption in US.