A Detailed Explanation of the Relationship Between the D-U-N-S Number and FDA Facility Registration

A detailed explanation of the relationship between the D-U-N-S Number and FDA facility registration

What is the D-U-N-S Number?

The D-U-N-S Number is a globally standard 9-digit unique enterprise identifier assigned by Dun & Bradstreet.

It is used to identify a single business entity, and is widely used by governments and enterprises worldwide as independent identity authentication for links such as supplier qualification, risk control, and credit review.

What is FDA facility registration?

FDA facility registration refers to the system by which the US Food and Drug Administration (FDA) requires facilities involved in the production, processing, packaging, storage, and other links of products such as food, drugs, cosmetics, and medical devices sold in the US to register with the FDA.

After successful registration, the FDA assigns a unique registration number (Facility Registration Number / Establishment Identifier).

The relationship between the two

Since 2003, the FDA has required that the relevant enterprise''s D-U-N-S Number be provided when performing facility registration.

The D-U-N-S Number has become the official unique enterprise identifier for FDA facility registration under federal food regulations (FSMA), used to verify the true identity of the business entity and its address.

Detailed explanation of core questions

Must the company name and address be consistent?

They must be consistent.

The facility name and address filled in during FDA facility registration must be completely consistent with the information found in the Dun & Bradstreet database.

If inconsistent, the FDA system''s verification will fail, causing registration delays, or requiring submission of additional supporting materials.

It is recommended that enterprises check and, if necessary, first update the information in the Dun & Bradstreet database before registration, to ensure consistency with the actual registration information.

Can one D-U-N-S Number correspond to multiple FDA facility registrations?

Yes, one D-U-N-S Number (one legal entity/company) can be associated with multiple FDA facility registrations.

The D-U-N-S Number identifies the "company entity", not a specific branch plant or production line.

Sometimes, if different "branches" under one company name have independent addresses, it is recommended to apply for an independent D-U-N-S Number for each.

How to handle facility information/address changes?

If an enterprise has a name/address change, it needs to first complete the update in the Dun & Bradstreet database, and then synchronously update the FDA facility registration information.