The FDA registers facilities; it approves or certifies no 3PL. Here is what an FDA-registered warehouse really is, which registration fits your product category, what changes in storage and fulfillment, and the questions to ask before you move inventory.
What an FDA-registered warehouse is, and why no 3PL is FDA-approved
FDA-regulated products are the goods the Food and Drug Administration oversees: food and beverages, dietary supplements, cosmetics, over-the-counter and prescription drugs, and medical devices. A warehouse that stores them cannot be FDA-approved or FDA-certified in any official sense. The FDA says it does not approve manufacturing facilities on their own, and that a facility's registration does not denote FDA approval. What does exist is registration. Facilities that manufacture, process, pack or hold food for consumption in the United States generally must register with the FDA, give an assurance that the FDA may inspect them, and renew every other year between October 1 and December 31 of each even-numbered year, so 2026 is a renewal year.
So when a 3PL's website says FDA-approved or FDA-certified, read it as a claim to hold an FDA registration. Then ask which registration it is, which building it covers, and whether you can see it.
Which FDA registration applies to your product category
The rules differ by product, which is why FDA-registered means little until you know which kind.
Food and dietary supplements: a warehouse that holds them for US consumption is a food facility, and FDA food facility registration covers dietary supplements as well as food and beverages.
Cosmetics: under the Modernization of Cosmetics Regulation Act of 2022, an establishment that only stores cosmetic products is not required to register, so a storage-only 3PL does not need a cosmetics registration.
Medical devices: a domestic distributor that does not import is not required to register, while relabelers, repackagers and initial importers are. A 3PL that relabels or kits your devices is in a different position from one that only stores them.
Prescription drugs: under the Drug Supply Chain Security Act, a 3PL must be licensed and report to the FDA every year to be an authorized trading partner, and the FDA explains how to check both. For OTC drugs, ask which licenses or registrations the facility holds for drug storage.
What changes in storage and fulfillment
The paperwork differs by category, and so does the floor work.
Dietary supplements: the FDA's supplement CGMP rule requires holding them under appropriate conditions of temperature, humidity and light, and requires distribution records. It applies to a warehouse that ships directly to consumers, so ask for climate records, not just a thermostat reading.
Food: shelf-stable goods need clean, pest-controlled ambient space, while refrigerated or frozen products need a 3PL with real cold storage and cold-chain packing. Some 3PLs, including one on this list, are ambient only. The FDA's Food Traceability Rule adds lot-level records for foods on its Food Traceability List, and the FDA will not enforce it before July 20, 2028.
Cosmetics: many beauty SKUs are heat-sensitive and carry batch codes and expiry dates, so lot capture at receiving and climate-controlled space matter.
Medical devices and prescription drugs: expect lot or serial traceability, quarantine space for returns and recalls, and, for prescription drugs, DSCSA licensing.
For food, supplements and cosmetics, FEFO (first expired, first out) rotation is common practice rather than an FDA requirement, while the drug CGMP rules require shipping the oldest approved stock first. Either way, rotation only works if the 3PL records lot and expiration dates when stock arrives.
Questions to ask a 3PL before you sign
Ask for documents, not just answers.
1. Registration: which FDA registration or license covers the building that will hold my stock, and can you show me the registration number or the facility's FDA Establishment Identifier (FEI)? A 3PL can show you its own.
2. Lot and expiry: do you capture lot and expiration date at receiving, pick FEFO, and record the lot on every outbound order?
3. Temperature: can I see temperature and humidity logs for the zone my products will sit in, and what happens when a reading goes out of range?
4. Recalls: when did you last run a recall drill, how long did it take to find every affected order, and can I see the report?
5. Food safety audits: do you hold an SQF or BRCGS certificate? These are GFSI-benchmarked schemes run by private certification bodies, not FDA requirements, but a current certificate means an outside auditor has reviewed the site.
6. Drugs and devices: which state licenses, DSCSA authorization or device registration apply, and will you relabel or kit my products, which can change what is required?
Costs, and how we ranked these 3PLs
Expect to pay more than standard fulfillment for climate-controlled or cold storage, lot and expiration capture at receiving, quarantine space, and the documentation work that registrations and audits require. Get quotes against your real product mix: categories, temperature ranges, SKU and lot counts, and order volume.
To choose, match your category to the registration or license it needs, shortlist two or three 3PLs, ask each the questions above for the specific building, tour it if you can, and run a paid trial before moving all your inventory.
How we ranked the list: each provider below says on its own website, captured September 28, 2026, that it operates an FDA-registered facility and tracks lots or expiration dates. Among those, brands placed through Fulfill.com and then customer reviews set the order. We have not inspected any facility, and no 3PL can pay for a higher ranking here.
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