FIG 08 / REGULATED PRODUCT
FDA Registered
Warehouse & Fulfillment
An FDA registered warehouse serving supplement, cosmetic, food and medical device brands nationwide from a single Houston facility. Climate controlled storage, lot and batch traceability, expiration managed FIFO picking, and records that hold up when somebody asks for them. Most of the US is inside a 2-day ground zone.
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THE DISTINCTION
Registered, Not Approved
The FDA registers facilities. It does not approve or certify them. Any 3PL selling you an “FDA approved warehouse” is selling a term that does not exist, which tells you something about how closely they read the requirements.
What protects your brand is the part underneath the registration: storage conditions matched to the product, categories kept separate, and a traceable record from the receiving dock to the outbound label.
FDA
REGISTERED FACILITY
40,000+
SQ FT CLIMATE CONTROLLED
Lot-Level
TRACEABILITY
FIFO
EXPIRATION MANAGED
TERMINOLOGY
Registered, Approved, Certified, Compliant
These four phrases get used interchangeably in 3PL marketing and only two of them mean anything. Here is what each one is actually claiming, and which ones we can hold up.
| TERM | WHAT IT ACTUALLY MEANS | ASFAR |
|---|---|---|
| FDA registered | The facility has filed its registration with the FDA and identified the product categories it handles. This is a real, checkable status. | Yes. Our Houston facility is FDA registered. |
| FDA approved | Not a thing for warehouses. The FDA approves drugs and certain devices, never buildings or logistics providers. | Nobody can be. A provider claiming it has not read the requirements. |
| FDA certified | Also not a thing. The FDA does not run a certification or accreditation program for warehouses or 3PLs. | Nobody can be. Ask for the registration instead. |
| FDA compliant | An informal way of saying the facility actually operates to the storage, sanitation, separation and recordkeeping standards it would be inspected against. | Yes, and it is the part that protects you. See the practices below. |
| cGMP | Current Good Manufacturing Practice. A manufacturing standard. Warehouses supporting cGMP brands need matching storage and traceability discipline. | We hold and handle cGMP manufactured product to those storage conditions. |
The practical version: ask any provider for the registration, then ask what happens to your lot records between the receiving dock and the outbound label. The first question has a one-word answer. The second one is where providers separate. Ask us both.
NATIONWIDE
A Houston Facility, A National Service Area
Most brands that store regulated product with us are not in Texas. Houston is where the building is, not the edge of the map.
FIG 01
ONE FACILITY, NATIONAL COVERAGE
Houston sits near the population center of the country, so a single FDA registered location reaches most of the US in two ground days instead of the three or four a coastal warehouse needs. Regulated brands get national delivery speed without splitting inventory across facilities and duplicating the compliance burden at each one.
FIG 02
NO SPLIT COMPLIANCE CHAIN
Every extra node in a network is another place lot records get re-keyed, another receiving process to audit, another partner to chase during a recall. Holding regulated inventory in one registered building keeps the chain of custody to a single set of records.
FIG 03
IMPORT STRAIGHT INTO COMPLIANT STORAGE
We are 10 minutes from Port Houston. Imported supplements, cosmetics and devices come off the container and into climate controlled, lot tracked racking the same day, with no inland freight leg spent sitting in an unregistered building first.
WHAT YOU GET
Compliance That Survives an Inspection
Registration gets you in the door. These are the parts that matter when someone actually checks.
FIG 01
FDA REGISTERED FACILITY
Our Houston warehouse is registered with the FDA to handle regulated product. That registration is the entry requirement, not the whole job, so it is backed by the storage conditions and records an inspection actually asks for.
FIG 02
LOT & BATCH TRACEABILITY
Lot numbers captured at receiving and carried through to the outbound shipment. Every unit that leaves can be traced back to the lot it arrived in, which is the difference between a contained recall and a total one.
FIG 03
EXPIRATION & FIFO CONTROL
Expiration dates tracked at the lot level and picking enforced oldest stock first. Short-dated inventory gets flagged while it can still be sold, not after it has quietly become a write-off.
WHY ASFAR
The Records Are the Product
Compliance failures are almost never storage failures. They are documentation failures found months later, when the lot in question has already shipped and nobody can say where it went.
Records Built at Receiving
Lot, quantity, condition and date captured on intake, because compliance records cannot be reconstructed later.
Category Separation
Regulated product stored apart from general freight rather than mixed into the same racking.
Recall-Ready Holds
Affected lots identified and frozen in place, with the record of where earlier units shipped.
One Partner, One Chain
Storage, prep and fulfillment in the same building, so the compliance chain is not handed between vendors.
Selling a regulated product?
Tell us the category, the volume and whether it is temperature sensitive, and we will come back with a straight answer on whether we are the right fit.
CATEGORIES
Who This Is Built For
Regulated ecommerce brands importing through Port Houston and selling across several channels at once.
FIG 04
SUPPLEMENTS & NUTRACEUTICALS
Capsules, powders and liquids that are heat and humidity sensitive, usually arriving by container and going out to Amazon, retail and D2C at the same time. Climate controlled storage with lot integrity intact across all three channels.
FIG 05
COSMETICS & SKINCARE
Emulsions, oils and actives that degrade in a hot warehouse and batch codes that have to stay readable and recorded. Kitting and gift sets built without losing the batch record on the component units.
FIG 06
FOOD, BEVERAGE & MEDICAL DEVICES
Shelf-life driven inventory where FIFO is not a preference and date coded stock has to rotate correctly. Product categories kept separated in the building rather than interleaved on the same rack.
FAQ
FDA Compliant Warehousing, Answered
Q01
Is there such a thing as an FDA approved warehouse?
Not exactly, and the distinction is worth knowing before you compare providers. The FDA does not approve, certify or accredit warehouses. It registers facilities that handle regulated product and inspects them against the requirements for those categories. What brands searching for an FDA approved warehouse or FDA certified 3PL actually need is a registered facility that follows the required storage, documentation and traceability practices. We are an FDA registered facility in Houston. Any provider advertising itself as FDA approved or FDA certified is describing something that does not exist.
Q02
What is an FDA registered fulfillment center?
A facility that has filed its FDA registration for the categories of regulated product it holds, and that picks, packs and ships those products under the storage and recordkeeping conditions it would be inspected against. The registration is the filing. The fulfillment part is what makes it useful to a brand: the same building that holds your supplements or cosmetics under climate control also picks the DTC order, keeps the lot number attached to the outbound shipment, and ships to Amazon, retail or the customer without handing regulated inventory to a second, unregistered warehouse.
Q03
Do you serve brands outside of Texas?
Yes. Most of the brands we hold regulated product for are not in Texas. Houston is where the warehouse is, not the limit of the service area. Houston sits near the population center of the country, so orders reach most of the continental US in two ground days from one facility, faster than a coastal warehouse and without splitting regulated inventory across multiple buildings. If you import, the port is 10 minutes away, so product moves from container into compliant storage the same day no matter where your company is based.
Q04
What does FDA registration actually require of a fulfillment facility?
Registration is the filing that identifies the facility and the categories it handles. The substance is what the facility can demonstrate on inspection: controlled storage conditions, sanitation and pest control, separation of product categories, records of what arrived and where it went, lot and batch traceability, expiration management, and the ability to isolate affected inventory quickly during a recall. If a provider cannot show you the records side, the registration alone does not protect you.
Q05
Which products need FDA compliant fulfillment?
Dietary supplements, cosmetics and skincare, food and beverage, and medical devices are the categories we see most from ecommerce brands. If a product is ingested, applied to the body, or used in a medical context, it is almost certainly regulated and your warehouse partner is part of your compliance picture either way.
Q06
Do you provide lot tracking and expiration date management?
Yes. Lot and batch numbers are captured at receiving and carried through to the outbound shipment, so any unit can be traced back to its lot. Expiration dates are tracked at the same level and picking runs FIFO, so short-dated stock moves before it becomes a write-off.
Q07
What happens if my product gets recalled?
We identify which lots are still on the shelf, hold them so nothing further ships, and produce the record of where units from the affected lot already went. Recall speed is almost entirely a records problem, and those records are either captured correctly at receiving or they are not.
Q08
Is the warehouse climate controlled?
Yes. The 40,000 sq ft Houston facility is climate controlled, which matters more on the Gulf Coast than most places. Heat and humidity are hard on supplements, cosmetics and anything with an oil, emulsion or active ingredient. Temperature sensitive product sits in climate monitored space, not just indoors.
Q09
Can you handle FDA regulated products going into Amazon FBA?
Yes, and it is a common pairing. Supplement and beauty brands need compliant storage on one side and Amazon prep on the other. We receive the container, store it correctly with lot tracking intact, then FNSKU label, polybag and ship to Amazon FCs from the same building, so the compliance chain is never broken by moving product between providers.