Many exporters assume FDA food facility registration is only for factories. The regulation is broader. It applies to facilities that manufacture or process, pack, or hold food for consumption in the United States, and FDA defines holding to include storage. A third-party warehouse, a cold store or an export consolidator can therefore need its own FDA registration even though it never opens a package or changes the product.
What FDA means by holding
Under 21 CFR 1.227, holding means storage of food, and it also includes activities performed incidental to storage and activities performed as a practical necessity for distributing that food. FDA's examples of holding facilities include warehouses, cold storage facilities, storage silos, grain elevators and liquid storage tanks. A facility is any establishment, structure or structures under one ownership at one general physical location; a private residence is not a facility. Registration is required before a facility begins to manufacture, process, pack or hold food for the US market.
Foreign warehouses and the further-processing exemption
A foreign facility does not have to register if its food undergoes further manufacturing or processing, including packaging, by another facility outside the United States. The exemption has a limit: if the later facility only adds labeling or performs a similar minor activity, the earlier facility must still register. Storage is not manufacturing or processing, so moving finished food into a warehouse does not exempt the factory that made it. In a common export chain, a manufacturer ships finished, packaged food to a separate cold store or consolidator, which then exports it. Both are manufacturing or holding food for the US market, and both generally need registration unless another exemption applies.
Every registered foreign facility needs a U.S. agent
Each registered foreign facility, including a foreign warehouse, must designate a U.S. agent who resides or maintains a place of business in the United States. FDA's definition rules out a mailbox, answering machine or answering service. The U.S. agent is the communications link between FDA and the foreign facility for both emergency and routine communications, and FDA contacts the U.S. agent in an emergency unless the registration names a different emergency contact. See why every foreign food facility needs a U.S. FDA agent.
Which operations are outside registration
The exemptions in 21 CFR 1.226 cover farms, retail food establishments, restaurants, nonprofit food establishments that prepare or serve food directly to consumers, certain fishing vessels and facilities regulated exclusively by USDA under the meat, poultry and egg products inspection laws. A logistics provider does not become exempt because it does not own the food or because the food stays sealed. Ownership of the food is not the test; the activity at the location is.
Registered storage-only sites still have food safety duties
Registration is the entry point, not the whole obligation. Under 21 CFR 117.7, the preventive controls and supply-chain program requirements of part 117, subparts C and G, do not apply to a facility solely engaged in the storage of unexposed packaged food. Such a facility remains subject to the modified requirements of 21 CFR 117.206 for unexposed packaged food that requires time and temperature control to prevent pathogen growth or toxin production, and to the current good manufacturing practice requirements that apply to holding food. Cold stores and consolidators that receive and ship foods on the Food Traceability List should also plan for the FSMA 204 records described in the FSMA 204 food traceability rule guide.
Registration details that matter for warehouses
A warehouse registration has to describe the facility's actual activity and the food product categories it handles, include a unique facility identifier, and be renewed between October 1 and December 31 of each even-numbered year. Changes to registered information must be submitted within 60 calendar days. A change of owner is handled differently: the former owner cancels the registration within 60 calendar days and the new owner submits a new registration. Identifier rules are explained in FDA registration numbers explained: FEI, DUNS and facility identification, and arrangements involving several companies at one site are covered in registration for contract manufacturers and multiple parties. For the current cycle, see what a 2026 food facility renewal must contain.
How FDABridge helps
FDABridge registers foreign food facilities, including warehouses and cold stores, handles the biennial renewal and obtains DUNS numbers where a facility does not yet have one. Service scope is set out on the pages for food facility registration and DUNS numbers, with U.S. agent coverage in selected registration services described on the U.S. Agent page. Registration does not mean FDA has approved a facility or its food, and it does not guarantee that any shipment will be admitted.
Sources: 21 CFR 1.225 to 1.234 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H); 21 CFR 117.7 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-A/section-117.7).