What an FDA-Registered Food Facility Means for a Food Brand

An FDA-registered food facility is a warehouse on file with the FDA under FD&C section 415, because it holds food for US consumption. The registration itself is only a filing. FSMA preventive controls (21 CFR Part 117) is a second requirement, met with a written food safety plan built from a hazard analysis. A food brand choosing a warehouse should confirm both.

By The Fulfillment.com team

Two requirements that often get mixed up

Food and beverage brands checking out a fulfillment partner often ask whether it is FDA-registered and stop there, as if that also covered FSMA preventive controls. It doesn't. The two come from different parts of the rules and are shown by different documents. A facility can meet one and still owe the other, so a brand that checks only registration knows less than it thinks.

Registration under FD&C section 415 tells the FDA that a facility exists and holds food. Packaged food, beverages and most CPG consumables all count as food for US consumption. Preventive controls under 21 CFR Part 117 is about how the facility runs. It calls for a written food safety plan, a hazard analysis, and records showing the plan is followed. Each one answers a different question a buyer has, and both are worth raising with any food and beverage fulfillment partner.

What "FDA-registered food facility" means

A warehouse that stores finished food and beverage is holding food for US consumption. Under the Federal Food, Drug, and Cosmetic Act, that means it registers with the FDA as a food facility (FD&C section 415). Holding the product is what sets this off. A facility that warehouses food and beverage has to register, whatever else it stores.

Here is what registration covers and what it leaves out.

• It is a required filing for any facility that holds, packs or stores food. The facility renews it every two years, and it comes with an FDA food-facility registration number that a brand can ask to see.
• It is not a food safety plan. The FDA doesn't inspect or "approve" a facility when it registers, and the section 415 filing says nothing about hazard analysis or preventive controls.
• It is not the same as being a manufacturer, co-packer or bottler. A warehouse that only stores and ships sealed product holds and distributes food without making it, so the registration that applies to it is the one for a facility that holds food.

A registration number confirms that the facility is on record as a food facility and works under the FDA's food rules. It is where checking starts. The food safety plan is the next thing to ask about.

What FSMA preventive controls (21 CFR Part 117) means

21 CFR Part 117 is the FSMA Preventive Controls for Human Food rule. Registration puts a facility on a list. Part 117 governs how the facility handles food from day to day. At its center is a written food safety plan, built from a hazard analysis. Under the plan, the facility:

• identifies the hazards reasonably likely to occur
• applies preventive controls where they are warranted
• monitors and verifies those controls
• takes corrective action when something drifts
• keeps the records that show all of it was done

How much the plan has to cover depends on the work. A warehouse holding finished goods and a food manufacturer owe different things under the same rule.

For a buyer, this changes what each claim is worth. "FDA-registered" describes the section 415 filing and nothing more. The label can be entirely accurate and still tell you nothing about whether a written food safety plan exists. A partner that says it follows FSMA preventive controls should be able to explain which Part 117 practices it follows, how it did its hazard analysis, and how it records monitoring. When a partner can't talk you through its plan, take that as your answer.

Registration tells you the facility is on the FDA's food-facility list. Preventive controls tells you a documented food safety system sits behind the way your product is handled. One can't stand in for the other. You will also hear about a third FSMA requirement, the Food Traceability rule, which is built on lot codes. We cover how those work in traceability lot codes and FSMA recall readiness.

How to check each one

You don't have to take either claim on trust. Each one is backed by a different piece of evidence.

• To check FDA registration, ask for the facility's FDA food-facility registration number under FD&C section 415. A facility that holds food has one, or should be able to tell you why it doesn't.
• To check FSMA preventive controls, ask which 21 CFR Part 117 practices the facility follows and how it built its hazard analysis. Ask, too, how it documents monitoring, corrective action and recordkeeping. A good answer points you to the written food safety plan and the records themselves. A badge or a logo on a sales sheet is no substitute.

Ask the two questions one at a time. "Are you FDA-compliant?" invites a single yes that covers both and proves neither. These two belong on a longer list you can use with any partner, which we set out in questions to ask a food and beverage 3PL.

Temperature control is a separate question

Brands sometimes fold one more thing into "are you FDA-compliant?": whether a product needs to be kept cold to stay safe. Registration and preventive controls don't answer that. It falls mostly under the FSMA Sanitary Transportation rule, and our guide to dry/ambient vs cold-chain food fulfillment explains where that line falls.

Our warehouses hold dry and ambient product, and some buildings are air-conditioned. We don't handle refrigerated or frozen product.

Where the difference shows up in daily work

Both requirements reach past the paperwork into how your product is handled. Registration places the facility under the FDA's food-facility rules. In a warehouse that holds food, a Part 117 plan is built around receiving, storage and recordkeeping. These are the practices worth asking any partner to walk you through:

• shipping by best-by or use-by date, nearest first (FEFO), and how lots with short dates are kept away from the shelves orders are picked from
• a traceability lot code recorded at receiving and carried through to each order
• shelf-stable storage
• records good enough that a recall pulls one lot, with no guessing about where it went

Our guide to traceability lot codes and FSMA recall readiness goes through the lot-code side in detail. With us, best-by dates and lot codes are recorded in BestOMS, our order system, with Deposco running the warehouse and Dropstream connecting your store and marketplaces.

Put both questions to every partner you are weighing, us included, and expect two separate answers rather than one blended claim. Our team will go through both for your product when you request a quote.