Agent must reside in the U.S., the Country/Area is automatically filled in with “United States.”. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm Examples of NDC number format If a company manufactures Drug A having 25 mg and 50 mg strengths in two pack sizes of 50’s and 100’s count, then the NDC number will be as follows. Choose: Owner, Operator, or Agent in Charge (Stop here, form is completed.) Example of a registration number is: MAL19976399X 2. The First name of the emergency contact person. The U.S. FDA Registration … The Registration Number is assigned to a facility by FDA. If you wish to change the Facility Location, you must Cancel this registration and begin a new registration. For foreign registrations, the three-digit country code of the telephone number for the parent company. Facility Location Information Screen Once you have completed the fields on this screen, click "Next" to be navigated to the Review Registration Information Screen. The state, province, or territory in which the parent company is located. If the facility conducts business under a name other than that entered in Section 2: Facility Name / Address Information then complete this section as identifying any alternate trade names will be required. The telephone number of the FAX machine of the parent company. If you wish to keep your original address as entered, select "Accept Provided Address" and continue with the registration process (Figure 8). The DUNS number is currently the only UFI approved by the FDA. Based on your facility’s activities, you may choose Food for Human Consumption and/or Food for Animal Consumption as shown in (Figure 13). If this is the first facility registration entered by this account holder this session, this option will copy the company address data from your account information. 12345-12-2567 and know you’re getting an equivalent product. The number assigned by FDA to this facility’s registration, The Personal Identification Number for this facility’s registration, The date your facility’s registration will expire. You may check all types of operations that are performed at this facility regarding the manufacturing/processing, packing or holding of food. Return to Update Options If you choose to edit facility information, a screen displaying all current information on record will appear. or -, Choose Section 3 if the parent company name/address is the same as the preferred mailing address information entered in Section, 3: Preferred Mailing Address Information. Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. (Figure 19, partial view) Selecting the EDIT button for a section brings up the corresponding data entry screen from which you can edit and save changes. Every foreign facility must have a U.S. The city in which the U.S. Specify whether the owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator or agent in charge of the facility is submitting this form. Specifies whether the parent company name/address information is identical to previously entered information. The telephone number of the FAX machine of the facility being registered. The middle name of the person acting as U. S. Agent for the foreign facility being registered. No. The name of the company that owns the facility being registered, if different from facility name. After you have logged in to FDA Industry Systems (FIS), choose "Food Facility Registration" from the list of available systems on the FDA Unified Registration and Listing System (FURLS) Account Management Home Page (Figure 1). The FAX number of the U. S. Agent that FDA can call 24 hours a day, 7 days a week, in case of emergency. Make sure that you have selected the appropriate registration number type (FEI or CFN), are using the correct date (“Validated by FDA” date, not any other date on the form) in the correct format … A Unique Facility Identifier (UFI) that allows users to identify the user’s facility through a unique number such as a DUNS number, For foreign registrations, the three-digit country code of the telephone number of the FAX machine for the facility being registered. The state, province, or territory in which the facility is located. The Last name of the emergency contact person. The first five digits of the NDC come from the labeler code. Select a state, province, or territory from the pull-down menu when applicable or select "Not applicable.". This will allow you to save a partially completed registration and return at a later time to complete the registration. Registration renewals with the FDA … Unless foreign facilities choose to designate another emergency contact, FDA will use their U.S. agent as the emergency contact. U.S. FDA does not issue any registration certificate however, as a third party firm, FDA Listing Inc. will provide you with a certificate of FDA registration that can be used as FDA registration … (v) FDA will then mail to the address or fax to the fax number on the registration form a copy of the registration as entered, confirmation of registration, and your registration number. If the changes made by the system are correct select "Accept Validated Address." This message pops up for other scenarios. (Figure 6c); The Facility Address and the Parent Company Address do not need to be in the same country/area. The telephone number of the U. S. Agent that FDA can call 24 hours a day, 7 days a week, in case of emergency. Select “No” if you do not take physical possession of the goods. 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