FDA-Registered & GMP Warehouse

Flexible Fulfillment That Keeps You Competitive

An FDA-registered warehouse is a storage and fulfillment facility formally registered with the U.S. Food and Drug Administration to handle products in regulated categories — supplements, cosmetics, medical devices, personal care, and specialty food — under conditions the agency can inspect.

Jay Group operates FDA-registered, cGMP-compliant warehouse space across facilities we own and run ourselves, which means the compliance controls behind your regulated product are managed by us, not brokered to a partner we don’t oversee.

For a regulated brand, that distinction is the difference between passing an audit and explaining one.

Why an FDA-Registered Warehouse Matters

If you sell a product the FDA regulates, where it’s stored is part of your compliance story, not a detail you can outsource and forget. A warehouse that mishandles lot control, lets dated product ship past expiration, or can’t isolate a suspect batch doesn’t just create an operational problem — it creates a regulatory one that lands on your brand. Registration signals that a facility handles regulated goods under conditions the FDA monitors, and cGMP compliance means the day-to-day processes inside it are documented and controlled to the same standard the agency expects of manufacturers. Plenty of 3PLs will store your product. Far fewer can stand behind it when an inspector, a retailer, or a recall asks how it was held.

What's Included in Our FDA-Registered Warehouse Services

Our GMP warehouse services cover the controls regulated brands actually get audited on:

FDA-registered, cGMP-compliant storage across every facility we operate
Real-time lot, batch, serial, and expiration-date tracking with FIFO/FEFO/LIFO rotation
Secure, temperature- and humidity-controlled zones
Quarantine and secure caged holding for suspect or on-hold inventory
Visual and manual inspection and sampling, including 100%/200% inspection projects
Recall support and full traceability
Custom SOPs and documentation for each program
ISO 27001-certified data security across sites
DEA-registered handling and hazmat capability for brands that need it

Services can be used on their own or combined, and each program is tuned to your SKUs and requirements rather than forced into a template.

The FDA-Registered Warehouse at Jay Group

Every Jay Group facility is FDA-registered and cGMP compliant — not one flagship building, but all of them, across the East, West, and central U.S. We own and operate that space rather than renting capacity inside someone else's network, so the SOPs, the controlled zones, and the tracking systems are ours to run and ours to answer for. That's a rare combination: an owned-and-operated footprint where compliance isn't a feature bolted onto a single site but the operating standard everywhere your inventory sits.

cGMP-compliant processes, documented end to end

A cGMP warehouse is only as good as its paperwork. We build custom SOPs for each project to document the work and set a baseline, so there’s a written, repeatable record of how your product is received, held, and shipped. Temperature and humidity in each facility are strictly monitored and controlled, with secure, climate-controlled zones for products that need them. When the standard is “prove it,” we can.

Lot, batch, and expiration tracking built in

Regulated product lives and dies by traceability. Every case in our warehouse is barcoded and carries its SKU information, including lot and expiration data, and we track lot numbers and expiration dates in real time through our Manhattan Associates WMS. That lets us run FIFO or FEFO rotation so dated product moves in the right order and nothing ships past its window. If a lot ever needs to be found, we can find it — down to the case.

Quarantine, inspection, and recall readiness

Compliance isn’t only about normal operations; it’s about the bad day. We maintain secure caged areas and can systemically quarantine product in anticipation of an FDA on-site observation, holding suspect inventory out of the sellable pool until it’s cleared. Our team runs visual and manual inspection services that support compliance requirements, with automation assisting operators on inspection projects at 100% or 200% levels. And if a recall happens, we can track lot numbers, expiration data, and the sales of affected items to isolate and account for what shipped.

The Technology Behind Our GMP Warehouse

The compliance controls above run on real systems, not spreadsheets. Case-level inventory, lot and expiration tracking, and FIFO/FEFO logic all live in our Manhattan Associates WMS — a longtime Leader in the Gartner Magic Quadrant for Warehouse Management Systems — paired with our proprietary order management system and a real-time client portal you actually log into. That gives you visibility into what’s on hand, what’s approaching expiration, and what’s in quarantine, without waiting for a monthly report. ISO 27001 certification across our facilities means the data behind that visibility is held to a recognized security standard, which matters when your product and your customers are both regulated.

Manhattan WMS (Enterprise Execution)

Jay Group operates on Manhattan Associates WMS, an enterprise warehouse management platform used by global supply chains. It supports high-volume operations and dependable execution.

3PL Software & Fulfillment Technology

Jay Group operates on Manhattan Associates WMS, an enterprise warehouse management platform used by global supply chains. It supports high-volume operations and dependable execution.

Order Management System

Jay Group operates on Manhattan Associates WMS, an enterprise warehouse management platform used by global supply chains. It supports high-volume operations and dependable execution.

Advanced Inventory Control & Reporting

Jay Group operates on Manhattan Associates WMS, an enterprise warehouse management platform used by global supply chains. It supports high-volume operations and dependable execution.

Facilities we own & operate across the East, West & Central U.S.

We are not an asset-light platform brokering your inventory to a network we don’t control. We own and run four facilities — Lancaster and Mountville, Pennsylvania in the East; Reno, Nevada in the West; and Houston, Texas in the Central/Gulf region — more than 750,000 square feet reaching over 90% of the U.S. within two days. For a wholesale program that means product positioned close to your retail buyers and their distribution centers, on floors we actually staff.

Lancaster, PA (HQ)

700 Indian Springs Dr, Lancaster, PA 17601

250K sq ft · 7-day fulfillment · ISO/IEC 27001

Mountville, PA

3750 Hempland Rd, Mountville, PA 17554

140K sq ft · FDA-registered · ISO/IEC 27001

Houston, TX

7677 Pinemont Dr, Houston, TX

250K sq ft · 7-day fulfillment · South & Central U.S.

Reno, NV

1381 Capital Blvd #200, Reno, NV 89502

130 K sq ft · FDA-registered · ISO/IEC 27001

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Why Jay Group for an FDA-Registered Warehouse

Most brands are told to pick between a compliance-serious operator and a modern, tech-forward one. We’re both — an owned-and-operated, FDA-registered, cGMP-compliant footprint running enterprise and proprietary software, staffed by people who stay. Family-owned and woman-led since 1965, we answer to clients, not outside investors, and we’ve maintained 99.9% order accuracy across six decades and a repeat spot on the Inc. 5000. When a compliance corner and a quarterly number are in tension, there’s no tension here to resolve. Before you trust any warehouse with a regulated product, ask two things: is every one of your facilities FDA-registered, and do you own the building my product sits in. Our answer to both has been yes for a long time.

Industries We Serve with FDA-Registered Warehousing

We built this capability for the categories where storage conditions carry regulatory weight — supplements and nutraceuticals, health and beauty, personal care, cosmetics, specialty food and beverage, medical devices, and other regulated brands. If your product needs FDA-registered handling, lot control, controlled-climate storage, or hazmat capability, our warehouse is built for it.

Supplement fulfillment

Beauty

Personal Care

Feminine Hygiene

FDA-Registered & GMP Warehouse FAQ

What is an FDA-registered warehouse?

An FDA-registered warehouse is a storage and fulfillment facility that has formally registered with the FDA to handle products in regulated categories. Registration means the facility holds regulated goods under conditions the agency can monitor and inspect. Every Jay Group facility is FDA-registered.

Is “FDA-registered” the same as “FDA-registered”?

No — and it’s a common misnomer. The FDA registers facilities; it doesn’t approve them. There is no such thing as an “FDA-registered warehouse.” A facility can be FDA-registered, meaning it’s on file and subject to inspection, but the agency doesn’t issue an approval or endorsement of a warehouse. If a 3PL claims to be “FDA-registered,” that’s a sign to look closer.

What does cGMP compliant mean for a warehouse?

cGMP stands for Current Good Manufacturing Practice — regulations enforced by the FDA. For a warehouse, cGMP compliance means the processes for receiving, storing, tracking, and shipping product are documented and controlled to that standard, with SOPs, environmental monitoring, and traceability in place.

How does Jay Group track lot numbers and expiration dates?

Every case is barcoded with its SKU, lot, and expiration information, and we track that data in real time in our Manhattan Associates WMS. That supports FIFO and FEFO rotation, quarantine, and recall traceability down to the individual case.

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Fulfillment decisions shouldn’t be based on assumptions. Let’s talk through your challenges & have a straightforward conversation about whether Jay Group is the right fit for your business right now – no pressure, just clarity.