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What is an FDA registered warehouse?
When should your warehouse be FDA certified?
How to register your warehouse with the FDA
ShipBob is a 3PL that’s FDA registered
ShipBob can help ship your products
What’s the difference between a t-shirt and a bag of chips? Besides one being able to satisfy hunger cravings, their requirements for inventory storage are quite different.
The ecommerce supply chain for products that are to be consumed, applied on skin, etc. rightfully have more regulations than those that don’t have as much risk in harming the public.
The US Food and Drug Administration (FDA) is a government agency responsible for the safety of the following products sold or manufactured in the United States:
- Food
- Dietary supplements
- Human drugs
- Vaccines
- Blood products
- Medical devices
- Radiation-emitting electronics
- Cosmetics
- Veterinarian products
- Tobacco products
The FDA inspects and enforces regulations related to these industries, including ensuring that the warehouses that store these products meet FDA regulations. The passage of the Food Safety Modernization Act (FSMA) in 2011 introduced new standards for food storage, processing, and manufacturing for this wide range of products.
Brands that sell highly regulated goods directly to consumers — especially packaged food products, vitamins and dietary supplements, beverages, medical products, and cosmetics — must make sure they use an FDA-certified warehouse.
What is an FDA registered warehouse?
An FDA registered warehouse is a storage location, food facility, or fulfilment centre that is registered with the FDA to store food, dietary supplements, drugs (prescription/medication), and other goods that are regulated by the FDA.
While the FDA only approves certain products (i.e., drugs, additives, etc.) and not companies, laboratories, buildings, or manufacturers, they do have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.
When should your warehouse be FDA certified?
Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with the FDA, unless an exemption applies.
In other words, having an FDA-certified warehouse is required if your ecommerce business sells anything from face creams and shampoos, to first aid kits and chocolate.
How to register your warehouse with the FDA
In order to become an FDA-certified warehouse, you must register your facilities with the FDA. By registering with the FDA, you agree to be inspected every three years. As long as you pass your inspections, your warehouse is considered to be approved by the FDA. View the FDA Registration and Listing page for more information.
ShipBob is a fulfilment partner that’s FDA registered
A benefit of outsourcing fulfilment is working with a third-party logistics (3PL) company that already holds a Certificate of FDA Registration. ShipBob’s warehouses are registered with the FDA (not certified by the FDA or regulated by the FDA), and you can utilise several of our logistics centres to reduce shipping costs and transit times.
ShipBob can help ship your products
ShipBob is a 3PL best-suited for products that don’t require approval by the FDA but are regulated by the FDA (e.g., cosmetics, dietary supplements, packaged and non-perishable food products, etc.).
Here are some examples of brands we’ve worked with to handle order fulfilment for their products in our FDA registered warehouses.
Dietary supplements
Women’s supplement brand Semaine Health quickly outgrew their first fulfilment partner, and needed a fulfilment platform that scaled with them. By outsourcing fulfilment to ShipBob and distributing inventory across our fulfilment network, Semaine Health saved $2/order on fulfilment costs and cut their shipping times by a third.
“We literally would not have been able to expand this year without ShipBob. In the past six months, we’ve quadrupled the number of orders that we’re shipping out. You might expect that that jump in volume would cause issues – but fulfilment has only gotten faster and better. That’s not how it typically works! ShipBob’s solutions have been game-changing for our brand.”
Matt Crane, Co-Founder and Chief Science Officer at Semaine Health
Read more dietary supplement brand case studies from ShipBob:
- Learn how supplement brand EnduroSport partnered with ShipBob to launch their brand and started shipping in just nine days here.
- Learn how fast-growing health and wellness brand Synchro managed unprecedented order volume working with ShipBob to fulfil their dietary supplements here.
Packaged food products
When it comes to food grade storage, I Heart Keenwah chose ShipBob. Outsourcing retail fulfilment of their delicious quinoa-based snacks has helped them free up more time for other areas of their business while increasing sales.
“ShipBob can process things more quickly than we could in-house and at scale. These time savings translate into cost savings as well.”
Sarah Chalos, Co-Founder and President, I Heart Keenwah
Read more food product case studies from ShipBob:
- Learn how meal replacement and nutrition company Ample Foods uses ShipBob’s warehouses, software, and fulfilment services to save money, bring 2-day shipping to more customers here.
- Learn how fast-growing health foods brand Synchro partnered with ShipBob to fulfil their powerfoods, nut butters, and other keto-friendly food products here.
- Learn how coffee creamer brand Prymal switched 3PLs to ShipBob and experienced 4x growth and $8,000 saved on shipping costs per month here.
Packaged drinks
Open Water sells water in aluminum cans to reduce the impact plastic bottles have on the environment. ShipBob fulfils all of Open Water’s orders, including Amazon orders. They tried fulfilment using FBA, but ShipBob did a better job of packing it correctly (their water comes in aluminum cans, which dent easily), had better rates, and Amazon was putting too much plastic in their orders, which doesn’t align well with their sustainable brand.
“We like having direct contacts on the ShipBob team. We now have better service and reduced lead times.”
Fernanda Gomez Ocejo, Director of Supply Chain at Open Water
Medical products
MDacne offers personalised acne treatments. They chose to partner with ShipBob to handle ecommerce fulfilment while they focus on increasing sales and delivering more value to customers.
Their business is almost all subscriptions, and ShipBob helps them offer reliable, affordable shipping that shows up at the same time each month. MDacne offers a free one-month supply as part of their initial three-month personalised acne treatment kit from their app. They also sell other products that can be purchased on their website like their Dark Spot Remover or Sunscreen, both formulated for acne-prone skin.
“Because ShipBob has a lot of people to handle our orders and additional warehouses we can expand into, we can scale up with ease as we continue to grow quickly. If we ran our own ecommerce warehouse, it would be much harder to hire people and we’d inevitably outgrow the space.”
Oded Harth, CEO & Co-Founder of MDacne
Safety as a #1 priority
Food safety is incredibly important as it can affect peoples’ lives. Issues with food safety have led to product recalls, outbreaks, and other negative consequences. At ShipBob, we take food safety compliance seriously in the following ways:
Quality control
ShipBob offers lot management to better track expiration dates in the event of a recall. A lot number is an identification number assigned to a particular quantity of material from a single manufacturer. The lot number enables tracing of the constituent parts or ingredients as well as labour and equipment records involved in the manufacturing of a product.
ShipBob’s lot feature allows you to separate items based on their lot numbers. When you send us a lot item, we will not store it with other non-lot items, or other lots of the same item. Our software’s logic is designed to always ship items with the closest expiration lot date.
Security
ShipBob employs state-of-the-art security at all facilities, keeping your ecommerce inventory as safe as possible. Our fulfilment centres have 24/7 security and are designed to store products safely. Additionally, our inventory management software helps you know exact inventory counts at each location.
Gain a logistics partner, not just a warehouse
Ecommerce businesses work with ShipBob because we make fulfilment easier. Instead of managing your own FDA-registered warehouse, ShipBob can take many inbound and outbound logistics tasks off your plate. By storing your inventory in our FDA-registered warehouses, you can save time and focus on other areas of your business.
To learn more about how ShipBob can help you manage fulfilment, click the button below to request a quote.
Have your own warehouse? Optimise it with a WMS
Need help managing fulfilment operations, but don’t want to outsource? ShipBob has a best-in-class warehouse management system (WMS) that brands can use in their own warehouse to improve inventory management, reduce errors, and scale in-house operations with ease.
Brands can even adopt a hybrid fulfilment model, employing ShipBob’s WMS technology in their own warehouses while simultaneously leveraging ShipBob’s fulfilment services in any of ShipBob’s fulfilment centres across the US, Canada, Europe, and Australia to improve cross-border shipping, reduce costs, and speed up deliveries.
FDA Approved Warehouse FAQs
Below are answers to common questions about FDA approved warehouses.
What are the FDA warehouse requirements?
For a warehouse to achieve FDA approval, the warehouse must:
- Completed FDA registration.
- Comply with regular on-site inspections.
- Create, implement, and present an in-depth Hazard Analysis Critical Control Points (HACCP) strategy to the FDA.
- Follow all federal sanitary operation standards.
Requirements may also vary by individual product or product category.
How do I verify if a warehouse is FDA approved?
The FDA will communicate with you to confirm that your warehouse is approved.
What are the benefits of choosing an FDA approved warehouse?
Choosing an FDA-approved warehouse is extremely beneficial for brands that sell consumable or medial products, as FDA warehouses enforce strict quality control, safety, and regulatory compliance measures. This gives both you and your customers peace of mind with regard to the integrity of any products you sell.
Is FDA approval the same as FDA registration for warehouses?
As long as you register your facility with the FDA and pass the subsequent inspections, your warehouse is considered to be approved by the FDA.
What happens if an FDA-approved warehouse violates regulations?
Violating regulations for FDA approved warehouses can have severe consequences. In addition to putting your customers’ health and safety at risk, your business may be subject to fines and your facility may be shut down.
