FDA Food Facility Registration User Guide
- June 4, 2024
- FDA
Table of Contents
FDA Food Facility Registration
IMPORTANT INSTRUCTION
Step 1 – Select the registration you want to update
Once you are logged in to FDA Industry Systems/your Online Account Administration (OAA) account, choose the “Food Facility Registration” (FFR) system. Next, choose the “Update Facility Registration” option from the FFR main menu
Figure 1 – FFRM Main Menu
The system displays a list of all the registrations associated with the account (Figure 2). To choose a particular registration, select the hyperlinked Registration Number to view options for updating that registration.
Note: Any registrations that are still due for renewal will not be displayed until you have successfully renewed them using the Biennial Renewal process.
If you are the main account holder (i.e., the Enterprise account), this list includes all the registrations created by your Subaccounts. If you are a Subaccount holder, this list only includes the registrations that are linked to the Subaccount. Note: You will also be asked for Broker Identification questions if you are updating a registration that did not have this information captured when the registration was created. These questions will identify whether your facility needs to be registered (see the Registration of Food Facilities user guide for information)
Figure 2 – Select Registration to Update
Step 2 – Review the Registration
If all the information is correct after review, select “Submit”. You may also select “Cancel” to leave the Update process. The system displays a message that your registration was successfully updated. If there is information that requires updating, continue to Step 3 – Indicate which section of the registration you want to update.
Step 3 – Indicate which section of the registration you want to update
Sections that may be updated have an “Edit” button displayed on the
registration review screen (Figure 3). Once you edit a section, you will need
to navigate through all the application sections to submit any changes.
Certain elements of the registration form are optional; updating those
optional items is not required but is strongly encouraged. To modify the PIN
for this registration, choose the “Modify PIN” link under Section 1.
Note: The Facility Location information (which indicates whether the
registration is a domestic or foreign facility) cannot be updated. If you wish
to change the Facility Location information, you must create a new
registration after cancelling the existing registration through the “Cancel
Registration” main menu option.
Figure 3 – Registration Review Screen
Step 4 – Update the Facility Information
Section 2 – Facility Name / Address Information Update the facility
name/address information.
Fields Included in this Section
Section 3 – Preferred Mailing Address Information
Update the Preferred Mailing Address Information. If the Preferred Mailing
Address is the same as the Facility Address, you should leave this section
blank. The Facility Address and the Preferred Mailing Address do not need to
be in the same country/area.
Fields Included in this Section
Section 4 – Parent Company Name / Address Information
Update the Parent Company Name / Address Information. The company that owns
the facility being registered is referred to as the Parent Company. If the
Facility and the Parent Company have different names, you must complete this
section; if they have the same name, leave this section blank. The Facility
Address and the Parent Company Address do not need to be in the same
country/area.
Fields Included in this Section
Section 5 -Facility Emergency Contact Information
Update the Facility Emergency Contact Information. FDA will use this
information in case of emergency to notify the tacility of the nature of the
emergency. Unless toreign facilities choose to designate another emergency
contact, FDA will use their U.S. agent as the emergency contact.
Fields Included in this Section
Section 6-Trade Names
If this facility conducts business under a name other than that entered in
Section 2: Facility Name/ Address Information then complete this section. For
example, complete this section if you describe your facility as “also doing
business as .. or “facility also known as…”
Fields Included in this Section
Section 7- United States Agent
Foreign facilities may update information about the United States Agent for
the facility being registered. Every foreign facility must have a U.S. Agent
who acts as the domestic communications representative for that facility. If
you indicated in Section 1: Ivpe of Registration, that the facility being
registered is a foreign facility, you are required to enter information about
the U.S. Agent. Domestic facilities do not require a U.S. Agent. Note: The
U.S. Agent should not be confused with the Agent in Charge, which is another
type of submitter for either domestic or foreign facilities.
Fields Included in this Section
Section 8 – Seasonal Facility Dates of Operation
Dates of operation refer to the months during which the facility is open for
business. If this facility operates on a seasonal basis, you may choose to
complete this section. You might enter, for example, March – September.
Fields Included in this Section
Section 9 – General Product Categories – Human/Animal/Both
Based on your facility’s activities, you may choose Food for Human Consumption and/or Food for Animal Consumption.
Section 9 (a/b) – General Product Categories – Food for Human/Animal/Both Consumption; and Type of Activity Conducted at the Facility
All facilities being registered must complete this information. Select as many categories as appropriate. Note: For more information about each of the categories included in Sections 9a and 9b, see the Product Code Builder and the relevant regulation (21 CFR 170.3). Section 10 – Owner, Operator, or Agent in Charge Information If the contact information for the owner, operator, or agent in charge is the same as that in another section of the form, select the appropriate option for that section; otherwise enter the information as requested.
Fields Included in this Section
Section 11 – Inspection Statement
Acknowledge that the FDA will be permitted to inspect the facility in the
manner permitted by the Federal Food, Drug and Cosmetics Act.
Section 12 – Certification Statement
After making other changes to the registration, you may update information
about yourself as the submitter of this registration or the person who
authorized submission of this registration and certify its truth and accuracy.
Once you have completed this section, you will be given the opportunity to
review your registration and make any changes before submitting it for
processing. 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, must submit this form. By submitting this form to FDA, the owner,
operator, or agent in charge or the individual authorized by the owner,
operator, or agent in charge, certifies that the information submitted is true
and accurate and that the facility has authorized the submitter to register on
its behalf. Under 18 U.S.C. 1001, anyone who makes a materially false,
fictitious, or fraudulent statement to the U.S. Government is subject to
criminal penalties
Fields Included in this Section
Step 5 – Review the Updated Registration
If all the information is updated, select Submit. You may also select “Cancel” to leave the “Update Registration” process but note that any changes made will be lost. The system displays that your registration was successfully updated.