U.S. FDA Registration
U.S. FDA Registration
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
- Created, caused, or was otherwise responsible for such reasonable probability; or
- Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
According to the U.S. FDA, beginning of October 1st, 2020 all registered food facilities must submit an FDA-recognized form of UFI during the 2020 food facility registration renewal period. The 2020 registration renewal period begins October 1st, 2020 and ends on December 31st, 2020. It will not be possible for the registered food facilities to renew their registration unless they have obtained and submitted the UFI. Currently, FDA only recognizes the Data Universal Numbering System (DUNS) number as an acceptable form of UFI.
If you are the owner, operator, in charge of multiple food facilities you must obtain and provide a separate DUNS number for each of my facilities at the time of registration renewal. All FDA-registered food facilities are required to renew their registrations during this period. Failure to renew the FDA registration will result in cancellation and removal of the FDA registration number.
ITA Corporation assists domestic and foreign food, drug, medical device and cosmetic manufacturing companies to register with US FDA and obtain DUNS Number.
Unlike medical device or drug establishment registration, food facility registration (bio-terrorism registration) cannot be verified through FDA website, but FDA registration number is required to export food products to the USA.
Under the supervision of an experienced attorney, food safety consultant and a technical expert, we provide quality, personal service to small-and medium-sized food and beverage exporters shipping food into the US.
US FDA is not issuing a registration certificate nor does US FDA recognize a registration certificate issued by private business. As your US FDA agent, ITA Corporation will verify the registration and issue FDA registration certificate for your records. The certificate of registration issued will help to make sure the registration process is complete and registration number is valid.
ITA Corporation is a Miami based regulatory consulting company and can assist you in obtaining the DUNS number as well as renewing your food facility registration as part of FDA registration and US agent services.
You can call us, or submit a form to get immediate assistance.