Why the FDA Rejects Food Facility Registrations: Common Mistakes Foreign Manufacturers Make

Foreign food manufacturers who submit FDA facility registrations without first verifying their prerequisites frequently encounter rejections, holds, and requests for correction that delay the registration by weeks. These rejections are almost entirely preventable. The FDA's system validation checks are straightforward, and the errors that trigger them are consistent. Understanding what causes rejections before submitting prevents the delays and costs associated with correcting them after the fact.

DUNS mismatch: the most common rejection trigger

The FDA validates the DUNS number submitted in a food facility registration against the Dun & Bradstreet database. If the legal business name on the FDA registration does not match the legal business name in the DUNS record exactly, the FDA's system flags the submission. The same applies to the physical address: if the address format in DUNS uses 'Road' and the FDA submission uses 'Rd.', the validation can fail. Foreign manufacturers who obtained a DUNS number years ago for a different purpose — banking, export documentation — may have a DUNS number with outdated or slightly different name and address information than what they intend to register with the FDA. Before submitting the FDA filing, the DUNS record should be verified against the exact information that will appear on the registration form.

Missing or incomplete US Agent information

The US Agent is a mandatory field in the FDA food facility registration. Submissions that omit the US Agent, list a US Agent who has not agreed to accept the designation, or list a US Agent address that is a PO Box rather than a physical US address are rejected. Some foreign manufacturers list themselves or their overseas headquarters as the US Agent, which does not satisfy the requirement because the US Agent must be physically located in the United States. The US Agent designation must be confirmed in writing before the FDA submission is made.

Incorrect product category codes

The FDA food facility registration requires the registrant to select the FDA product category codes that describe the food products manufactured at the facility. These category codes are drawn from a specific FDA list and must accurately reflect the products actually made at the facility. Registrations that select overly broad categories — for example, selecting all beverage categories when the facility only makes one type of juice — are not automatically rejected, but they create mismatches when the FDA compares the registration to import data. Conversely, registrations that omit a product category that the facility actually manufactures can result in shipments of that product being treated as coming from an unregistered facility for that product type.

Submitting before the DUNS number is fully processed

Some foreign manufacturers apply for their DUNS number and immediately attempt to submit their FDA registration before the DUNS record has propagated to the D&B database system that the FDA queries. The DUNS number may exist in D&B's internal systems but not yet be visible to the FDA's validation query. Standard processing for a new DUNS number is five to ten business days. Submitting the FDA registration within the first day or two after the DUNS application is accepted is a common timing error that results in a validation failure even when the DUNS number itself is correct.

How FDABridge prevents registration errors

FDABridge verifies DUNS records, US Agent designation, product category codes, and submission timing before every FDA food facility registration submission. Our pre-filing review catches the errors that cause rejections before they reach the FDA system. Visit fdabridge.com/food to learn about our registration services or fdabridge.com/apply/food to start.