FDA Food Facility Registration for Contract Manufacturers: Who Registers When Multiple Parties Are Involved

Contract manufacturing is the norm in the global food industry — a brand owner in one country hires a manufacturer in another country to produce products under the brand owner's label for export to the United States. This arrangement raises a question that many first-time exporters struggle to answer: who must register with the FDA as a food facility? The answer depends on who is doing the manufacturing, processing, packing, or holding, and the rules apply to every entity in the supply chain that performs one of these functions — not just the entity whose name appears on the label.

The FDA registration requirement and who it covers

Under Section 415 of the FD&C Act and 21 CFR Part 1, Subpart H, every domestic or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA. The registration requirement applies to the facility — the physical location where food-related activities occur — not to the brand, the legal entity, or the business relationship between parties. This means that a contract manufacturer that produces food for a US-bound brand must register its own facility with the FDA, regardless of whether the brand owner has a separate registration for its own operations. The brand owner's registration, if any, does not cover the contract manufacturer's facility, and the contract manufacturer's registration does not cover the brand owner's warehouse or distribution center if those facilities also handle the food.

Common contract manufacturing scenarios

In the most common arrangement, a foreign brand owner contracts with a foreign manufacturer to produce food that will be exported to the United States. In this case, the foreign manufacturer's facility — where the food is actually manufactured or processed — must be registered with the FDA. The brand owner may or may not need to register separately, depending on whether the brand owner's own facilities perform any manufacturing, processing, packing, or holding of the food. If the brand owner merely designs the product, arranges the contract, and manages the commercial relationship without physically handling the food, the brand owner's office does not need to be registered as a food facility.

In another common arrangement, a foreign manufacturer produces a base product (such as a sauce, paste, or flavoring), ships it to a second foreign facility for repackaging into retail containers, and the repackaged product is then exported to the US. In this case, both the manufacturing facility and the repackaging facility must register with the FDA, because both are performing regulated activities — one is manufacturing and the other is packing. Similarly, if a third-party warehouse in the exporting country holds the finished product before shipment, that warehouse may also need to register if it is holding food for US consumption, although there are exemptions for certain types of holding.

US Agent designation in contract manufacturing

Each foreign facility that registers with the FDA must designate its own US Agent. A contract manufacturer cannot use the brand owner's US Agent unless that agent has agreed to serve both facilities — the US Agent designation is facility-specific, and each facility must have its own designated agent recorded in the FDA's registration system. If the brand owner and the contract manufacturer want to use the same US Agent service provider (such as FDABridge), that is permitted, but two separate designations must be made in the system.

DUNS number requirements for contract facilities

Each facility that registers with the FDA needs its own DUNS number, matching the exact legal entity name and address of the facility. A contract manufacturer cannot use the brand owner's DUNS number, and a brand owner cannot use the contract manufacturer's DUNS number. If the contract manufacturer operates multiple facilities that produce food for US export, each facility needs its own DUNS number and its own FDA registration. The DUNS number must be obtained from Dun & Bradstreet before the FDA registration can be completed, and the information in the DUNS record must match the information submitted to the FDA — any discrepancy between the DUNS name or address and the FDA registration will cause the registration to be flagged or rejected.

Labeling implications

The name and address that appears on the food label must identify the manufacturer, packer, or distributor. Under 21 CFR 101.5, if the entity named on the label is not the manufacturer, the label must include a qualifying phrase such as 'manufactured for,' 'distributed by,' or 'packed for' followed by the name and address of the responsible entity. This is a labeling requirement, not a registration requirement — the entity named on the label does not need to be the FDA-registered facility, but the facility where the food was manufactured or packed must have its own registration regardless of what appears on the label. Foreign brand owners who contract with multiple manufacturers sometimes make the mistake of assuming that their own FDA registration covers all products bearing their brand name, regardless of where those products are made.

How FDABridge handles contract manufacturing registrations

FDABridge registers both brand owners and their contract manufacturers with the FDA, ensuring each facility has its own DUNS number, its own FDA registration, and its own US Agent designation. We coordinate the registration process across multiple facilities and multiple countries, so that the entire supply chain is compliant before the first shipment is sent. Visit fdabridge.com/food to see our food registration services or fdabridge.com/contact to discuss your contract manufacturing compliance needs.