The FDA regulates more than $2.5 trillion in consumption of food, medical products, and tobacco. This makes FDA compliance a large priority for the brands and manufacturers of over 267,000 products. Failing to follow the FDA’s policies and procedures can result in costly fines or even closure for these companies.
FDA approved 3PLs help companies ensure compliance. But not all FDA registered 3PLs are the same.
What Does FDA Certified Really Mean?
If a 3PL is FDA certified, a brand can know for sure its facilities are clean and well-maintained. Unfortunately, that is where the similarities across FDA certified 3PLs end.
Not All FDA Certified 3PLs Are the Same
Just because a 3PL is FDA certified doesn’t mean they have the ability to handle all products. Different products require different shipping conditions. For example, medicine is required to be kept at a specific temperature range. Band-Aids require a lower temperature range. Tampons don’t require a climate controlled environment but are still considered a medical device and need to be shipped by an FDA certified facility. This is why FDA certifications are product specific.
Does cGMP Compliance Cover it?
There is much overlap between FDA protected products and cGMP (Current Good Manufacturing Practices) compliance, which can beg the question “Is cGMP compliance enough?” In short, no it is not enough. If a business is shipping food, beverage or dietary supplements intended for consumption by humans or animals, the FDA requires it to use a FDA certified 3PL facility. This is why leading fulfillment companies will possess both FDA certification and cGMP compliance.
Product Specific FDA Requirements:
The four most common types of products that need FDA certified 3PLs are medical devices, food and beverages, pharmaceutical products, and nutraceutical products. Each, of course, has different requirements:
The FDA segments medical devices into Class 1, Class 2, or Class 3, based upon the risk of the product. Similarly, a 3PL can be certified to handle only Class 1 devices up to Class 1-3 devices.
Food & Beverage
The minutia of differences in FDA certified 3PLs that service the Food & Beverage industry ranks in the hundreds. Specific items to be aware of as you’re choosing a 3PL partner is if they can handle organic foods and allergy-free foods. Each requires additional procedures to be followed.
In order for fulfillment companies to service Pharmaceutical products, strict procedures must be in place around product tracing and product 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 FDA on-site observation and inspection.
Traditionally, the FDA has been hands-off with dietary supplement and nutraceutical products; however, earlier this year, the FDA began enforcing stricter policies for supplements marketed to treat Alzheimer’s. The FDA also announced it was beginning a large modernization to the current dietary supplement regulations.
Questions to Ask When Evaluating a 3PL
Registering with the FDA is easy, and anyone can do it, which makes asking the right questions when choosing a 3PL very important. Below are a few key questions to include in an evaluation:
- 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?
- 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?
Additional Industries that Require FDA Certification:
It isn’t just the food & beverage, medical, pharmaceutical, and nutraceutical industries that need to be aware of these regulations. Additional industries include:
- Alternative wellness products (certain essential oils or CBD oil)
- Cosmetics (nail polish, hair care products, and perfumes)
- Personal Care Products
- Building Supplies (adhesives and paints, varnish, shellac, polish, and lacquer)
KNOW BEFORE YOU SHIP: As a FDA Registered and cGMP compliant fulfillment company, The Jay Group is one of a small percentage of third-party-logistics providers qualified to serve the needs of highly regulated industries. Contact us to learn more.