The Ultimate Guide to FDA Registered Warehouses for E-Commerce

Ben Eachus
5 min read August 21, 2020

FDA registered warehouses and logistics for e-commerce brands may be hard to say in one breath, but they’re also necessary if you aim to sell goods directly to consumers in the United States legally.

Fortunately, this Ultimate Guide to FDA Registered Warehouses for E-Commerce has everything you need to know about FDA-regulated products and their facilities.

What is an FDA-Certified Registered Warehouse

The role of the Food and Drug Administration (FDA) is to protect the public health by assuring foods, drugs, vaccines, biological products, and medical devices are labeled, sanitary, and safe for human use and/or consumption. The FDA regulates a wide range of products, including:

●  Foods (except for those regulated by the U.S. Department of Agriculture)

●  Human and veterinary drugs

●  Vaccines and other biological products

●  Medical devices intended for human use

●  Radiation-emitting electronic products

●  Cosmetics

●  Dietary supplements

●  Tobacco products

Like the facilities that produce these products, organizations that store, repack, or re-label products in the industries mentioned above must register with the FDA. Therefore, an FDA certified warehouse is any storage facility and/or fulfillment center that has been registered with the FDA and approved to store FDA regulated products.

To retain its FDA certification, an organization must agree to and pass an FDA inspection every three years to ensure strict quality standards over their storage, packing, and shipping processes. In order to verify compliance with good manufacturing practice regulations, the FDA has the authority to inspect a registered facility.

Do I Have to Register My Warehouse With the FDA

The short answer is… it depends. The FDA’s regulatory authority is very broad and covers everything from medicine to microwaves. Unfortunately, the FDA also admits that it is “often frustrating and confusing for consumers determining the appropriate regulatory agency to contact.”

So, we included the following list of FDA centers and offices to contact if you need to determine whether you need to register your warehouse with the FDA:

●  Center for Food Safety and Applied Nutrition (CFSAN, includes Cosmetics)

●  Center for Drug Evaluation and Research (CDER)

●  Center for Devices and Radiological Health (CDRH)

●  Center for Biologics Evaluation and Research (CBER)

●  Center for Veterinary Medicine (CVM)

Product Specific FDA Requirements

The four most common types of products that require FDA certification are medical devices, food and beverages, pharmaceutical products, and nutraceutical products (dietary and nutritional supplements).

That being said, the following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction (this is not an exhaustive list):

●  Packaged Foods (such as dietary supplements, bottled water, food additives, infant formulas, and other food products.)

●  Consumer Products (such as toys, cribs, power tools, cigarette lighters, household chemicals, and other products that pose a fire, electrical, chemical or mechanical hazard.)

●  Cosmetic Products (such as color additives found in makeup and other personal care products, skin moisturizers, cleansers, nail polish, and perfume.)

●  Veterinary Products (such as livestock feeds, pet foods, veterinary drugs, and devices.)

●  Radiation Emitting Electronic Products (such as microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps.)

●  Medical Devices (such as tongue depressors, bedpans, heart pacemakers, dental devices, surgical implants, and prosthetics.)

●  Building Supplies (such as adhesives and paints, varnish, shellac, polish, and lacquer)

●  Prescription drugs and non-prescription drugs

●  Tobacco Products (such as cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.)

Specific Requirements for Medical Devices

Medical devices are more highly regulated by the FDA than other products. In order to sell or market a medical device, companies need to register annually with the FDA. The manufacturer must also list their medical devices in the FDA’s Registration and Listing database.

FDA registration only indicates that the FDA is aware of the manufacturer and their medical devices. FDA registration does not imply whether the medical device is an effective treatment for the issue the manufacturer intended it for.

Misuse of Certificates and the FDA Logo

Companies cannot use the FDA logo in marketing their products without the FDA’s authorization. The logo is for FDA purposes only and using it without permission suggests that the FDA endorses the product or organization which violates FDA policy.

The use of FDA certificates to imply FDA approval is also prohibited. For example, some companies may try to sell a medical device by displaying an FDA registration certificate with it. Since the FDA does not issue device registration certificates, this would be misleading consumers to believe their product has FDA approval.

Are 3PLs FDA Certified

Third-party logistics providers can be FDA approved, but not all FDA registered 3PLs are the same. Anyone can fill out the right forms to be FDA certified, but certifications only ensure the bare minimum. If you’re looking for a 3PL that goes above and beyond the bare minimum required by the FDA, Flowspace is your only option.

Flowspace: Safe, Sanitary, and Secure

Unlike traditional 3PLs, Flowspace enables online retailers with the security, quality, and temperature control they need, when and wherever they need it. With a network of more than 1000 warehouses and fulfillment centers, Flowspace is uniquely suited to store, process, and ship all of your FDA regulated products.

We offer a suite of solutions to help you grow your business; manage your warehouse and ensure FDA-level quality control at every step in your supply chain, including:

●  Special Handling

●  Tracking and Monitoring

●  Temperature and Quality Control

●  State-of-the-art Security

Flowspace Certified Warehouse Network

Our network of 1000+ warehouses and fulfillment centers is registered with the FDA; they are optimized to ensure the safety of the products stored there. That’s why so many e-commerce brands choose to work with Flowspace, because we have the experience and focus to keep specialty products in excellent condition.

As an FDA Registered compliant fulfillment company, Flowspace is a very small percentage of third-party logistics providers with the qualification to serve the needs of your highly regulated industries. Contact us today to get started.

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