Application for US FDA Registration of Food Facility

Regulatory Requirements

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.

Required Documents

* Company name, complete address, phone number, and emergency contact phone number.

* Unique Facility Identifiers (UFI)

* Preferred mailing address (if different from company information).

* Parent company name, address, and phone number (if applicable).

* All trade and trademark names used by the company.

* Name, complete address, and phone number of the owner, operator, or responsible agent.

* Email address of the owner, operator, or responsible agent, unless exempted by FDA under 21 CFR 1.245.

* Food category (according to FDA 3537 classification specification).

* Activity types conducted for each food category (according to 21 CFR 1.232(a)(8) classification specification).

* Declaration of accepting FDA factory inspection.

* Declaration of the accuracy and truthfulness of the submitted information.

* Name, complete address, phone number, and email address of the US agent for foreign companies (if applicable).

* Emergency contact phone number and email address for foreign companies (if applicable).

Note:

All food facilities are required to submit Unique Facility Identifier (UFI) as part of their initial FDA registration as well as their registration renewal. Currently, the only UFI recognized by FDA is the DUNS number.

Application Fees

* The FDA does not charge any application fees for the certification process.

* However, there may be certain testing and agency fees incurred during the material preparation stage of the application process.

Application Time Frame

* If the company already has a Duns number, the entire registration process can typically be completed within one month.

* If the company does not yet have a Duns number, the process of applying for a Duns number usually takes around 45 days.

Our Services

* Food Facility Registration in the US

* Application for Duns number

* Other Customized Services