The FDA regulates more than $2.5 trillion in the consumption of food, medical products, and tobacco. If you’re a business in the medical device, pharmaceutical, nutraceutical, or food and beverage space, failing to follow the FDA’s policies and procedures can result in costly fines, penalties, and even the closing of your business. In this blog, we’ll explore how an FDA-registered 3PL facility can help you stay FDA compliant, avoid penalties, and ultimately provide the best service possible to your clients.
What Does FDA Certified Mean?
The U.S. Food and Drug Administration (FDA) is a government agency overseeing the safety of the following products:
- 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 and non-prescription drugs
- Tobacco products (such as cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco).
For a 3PL to be FDA registered, approved, and certified, it must adhere to the unique storing, packaging, and shipping regulations for each of the sensitive products it handles. It also must have FDA-approved facilities.
FDA-Registered and Temperature-Controlled Warehouses
While an FDA registered 3PL facility is a good start, it doesn’t mean every warehouse bearing this moniker has the ability to handle any type of product. In addition to finding an FDA-registered warehouse, it’s important to partner with a 3PL that has temperature-controlled facilities.
Different products require different shipping conditions. They also have various FDA shipping restrictions. For example, certain types of medicines and vaccines are required to be kept at a lower temperature range (even during transit), while other products like shelf-stable food and beverage items can be kept in a larger temperature range zone.
cGMP Compliance
Current Good Manufacturing Practices (cGMP) are FDA regulations that guide the design, monitoring, and maintenance of manufacturing facilities and processes. When looking for a 3PL to partner with, you’ll want to find one that is cGMP compliant.
Is cGMP Compliance Enough?
While there’s certainly overlap between FDA-protected products and cGMP compliance, that doesn’t mean that cGMP compliance alone is enough. If your business is involved in shipping food, beverages, or dietary supplements, the FDA requires you to partner with an FDA-certified facility. A leading 3PL facility will possess an FDA certification and be cGMP compliant.
Product-Specific FDA Requirements
The most common types of products that require an FDA-approved 3PL are medical devices, food and beverages, nutraceuticals, and pharmaceutical products. Each of these product classes may have different regulations, and the FDA will enforce different shipping regulations depending on the product. So it’s important that the 3PL you partner with is also experienced in logistics.
Medical Devices
The FDA segments medical devices into Class 1, Class 2, or Class 3 based upon the risk of the product. A 3PL may be certified to handle only Class 1 devices while a different one can work with Class 1-3 devices.
Food & Beverage
The minutiae of differences in FDA-approved 3PLs that service the food and beverage industry ranks in the hundreds. One item to be aware of when choosing a 3PL partner is whether they can handle organic and allergy-free foods. Each requires additional procedures that you must follow.
Pharmaceutical
In order for fulfillment companies to service pharmaceutical products, strict procedures must be in place around product tracing and verification.
- Product tracing: a 3PL must have lot-level product tracing procedures in place. By 2023, the FDA expects product tracing to be at the package level.
- Product verification: systems must be in place so that products can be quarantined in anticipation of on-site FDA observation and inspection.
Nutraceutical
Traditionally, the FDA has been hands-off with dietary supplements and nutraceutical products. However, the FDA has begun enforcing stricter policies for supplements marketed to treat Alzheimer’s. They’ve also announced a large undertaking to modernize current dietary supplement regulations to ensure safety protocols are being met.
Additional Industries That Require FDA Certification
It isn’t just the food and beverage, medical, pharmaceutical, and nutraceutical industries that should be aware of the importance of partnering with an FDA-registered facility. Businesses in any space that offer products intended for consumption or use by humans or animals will most likely be required to use a 3PL that’s registered and approved by the FDA. For regulations and compliance requirements unique to your business, you can find more information here.
FDA Shipping Requirements and Best Practices
Amongst products that require FDA approval or registration, food safety is one of the most important. Issues with food safety have led to product recalls, outbreaks, and other negative consequences. If your business offers food and beverage products, it’s especially important to partner with a 3PL that prioritizes safety best practices.
Quality Control
An FDA-registered 3PL with temperature-controlled facilities helps protect against wasted products and spoiling. The shipping process is also crucial, and partnering with a 3PL experienced in shipping sensitive and even hazardous materials can be the difference between your product making it to your customer intact or spoiling in transit.
Security
It’s also important to find a 3PL that employs state-of-the-art security at all facilities. With optimized space and automated technologies, an experienced 3PL can keep your inventory as safe as possible. Additionally, inventory management software helps you know exact inventory counts at each location, helping you avoid overstock or stock-out.
Questions to Ask When Evaluating a 3PL
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 what’s required by the FDA, here are a few key questions to ask:
- Does the 3PL have a QMS (Quality Management System)?
- Do they perform annual audits?
- Do they follow through on CAPAs (Corrective and Preventative Action)?
- How does their system handle recalls and returns?
- Does the system track lot and expiration at the individual order level, or does it only track based on dates shipped?
- Has the company been independently audited?
- Will the 3PL allow you to audit their facility?
Your business focuses on many things, but worrying about compliance in a highly-regulated industry shouldn’t be one of them. To learn more about our FDA-registered facilities, contact us and we’d love to speak with you.
This blog was originally published on June 11, 2019. It was updated on November 9, 2021.