What Documents to Prepare Before Starting FDA Food Facility Registration

Foreign manufacturers who open the FDA's FURLS registration system without first assembling all required information and documents regularly encounter a registration that takes far longer than necessary to complete. The FURLS system does not save partial submissions reliably across sessions, and attempting to gather required information mid-filing while the form is open creates errors. The correct approach is to collect every required piece of information before the filing is started, then complete the filing in a single focused session.

Legal entity name and physical address

The single most important document verification before starting an FDA food facility registration is confirming the exact legal name and physical address of the facility as they appear in the DUNS record. The DUNS record name and address are the reference against which the FDA validates the registration submission. Any deviation — different punctuation, abbreviated versus spelled-out words, postal code format — can cause a validation failure. Before opening the FDA registration form, the DUNS record should be pulled and the exact spelling, formatting, and address structure confirmed. That exact text is what gets entered on the FDA form.

The DUNS number itself

The nine-digit DUNS number must be on hand before the filing begins. If a DUNS has been previously obtained, confirm it is assigned to the correct legal entity and physical address, not to a parent company, a different facility location, or a related entity. If no DUNS exists, allow five to ten business days after application before attempting the FDA filing — the FDA validates the DUNS number against the D&B database in real time, and a number that has not yet propagated through D&B's system will fail validation.

US Agent contact information

The US Agent's full name (individual or company name), US physical address, US phone number, and email address must be in hand before the filing. The US Agent must have already agreed to accept the designation — the FDA registration form asks the registrant to confirm that the US Agent has been notified and accepts the role. A US Agent who is designated in an FDA filing without prior written agreement has not properly accepted the designation. If using FDABridge as the US Agent, the specific contact details for the FDABridge US Agent service must be used exactly as provided.

Product category information

The FDA food facility registration requires selection of the food product categories manufactured at the facility using the FDA's defined category codes. The registrant should review the FDA's complete category code list in advance and identify all applicable categories. A facility that manufactures fruit juices, vegetable juices, and flavored waters should identify the specific FDA category code for each product type rather than defaulting to the broadest possible category. The category selections become part of the permanent registration record and are referenced in import system checks for each incoming shipment.

Facility owner and operator information

The FDA registration requires both the owner of the facility (the legal entity that owns the physical property and equipment) and the operator of the facility (the legal entity responsible for the food manufacturing operations) to be identified. For many foreign manufacturers, the owner and operator are the same legal entity. Where they differ — for example, a manufacturer leasing a facility from a property company — both must be listed separately. The legal names and addresses for both must be accurate and consistent with official corporate registration documents.

How FDABridge handles document collection and verification

FDABridge conducts a pre-filing document review for every food facility registration we manage, verifying DUNS records, legal entity names, addresses, and US Agent information before submission. Our intake process is designed to collect exactly what the FDA filing requires — nothing is left to be gathered mid-session. Visit fdabridge.com/food to see our services or fdabridge.com/apply/food to begin.