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May 23, 2017

Doing Business with FDA-Regulated Products

Do you sell, or plan on selling, products that are regulated by the FDA? If you sell anything meant to be consumed internally by a person or a pet, then the answer is probably “yes.” The FDA regulates a wide range of products, including foods, human and veterinary drugs, vaccines, medical devices intended for human use, radiation-emitting electronic products, cosmetics, dietary supplements, and tobacco products.

If you sell FDA-regulated products, there are a number of things you will have to do to ensure you are doing business in a way that complies with the FDA’s standards. First and foremost, you will need to make sure that any storage and shipment facilities you use are also in compliance. This is where your products are the most vulnerable. If you do not have the resources in-house to ensure compliance, you might need to look into outsourcing to a 3PL with appropriate facilities and procedures.

Here, then, is what you should look for:

Is the Facility Really Registered with the FDA?

Buyer beware: Any organization can claim that they are an “FDA facility.” But this phrase means next to nothing. Unless they are registered with the FDA, with a registration number to prove it, then they are in violation of FDA regulations.

Is There Appropriate Climate Control?

Most products have a range in which they will stay maximally fresh and ready for consumer use. Temperatures outside of that range risk spoiling the product. If your products need to stay within a specific temperature range, it is well worth asking not only what temperatures are maintained, but how:

  • What is the ambient temperature of the facility? How much does it vary throughout the course of a day? A year? Which areas are simply allowed to stay at those temperatures?
  • Which parts of the facility have a broad range of allowed temperatures? This will likely be areas that are regulated only when the ambient temperature gets above or below a certain threshold. For example, at our facilities, we have areas that maintain a range of temperatures from 50 to 85 degrees Fahrenheit. This is suitable for most cosmetics, dietary supplements, and so on.
  • Are there any parts of the facility that provide cool storage or refrigerated storage at a specific temperature? Again, at our facilities, we have a vault specifically built to maintain a temperature in the 60-degree range. This is especially good for products that do not need refrigeration per se but where cool storage maintains shelf life or where temperature fluctuations can affect the product.
  • Are there any parts of the facility that provide frozen storage if needed?

Again, your specific products will dictate the kind of temperature control that you need. Just be aware that there are more types of storage than just “refrigerated” or “unrefrigerated.” With many products, controlling the variance in temperature is much more important than keeping the products cool!

What Kinds of Pest Control Are in Place?

Pests are a constant worry, no matter where your facilities are located. In fact, most pests come in with products themselves! Every facility should have measures in place to ensure that these pests are contained and pose no risk to products. Some examples include:

  • Rodent traps
  • Insect control programs
  • Screens on doorways (to minimize bugs entering the facility when doors are opened)
  • Pheromone traps to monitor for meal moth issues

What Other Policies Are in Place to Prevent Contamination?

There are several other policies that need to be in place (and enforced) to guarantee a clean, risk-free facility. While some of these are common sense, all of them need to have explicit safeguards in place to make sure anti-contamination policies are being followed. For example:

  • Employees need to wash their hands after using the restroom. Reminders should be posted in restrooms, which also need to be appropriately stocked.
  • Employees should be encouraged to report any active case of illness to supervisors before beginning work.
  • If an employee receives a minor injury on the job—a small cut, say—appropriate first aid should be applied. If the employee then goes back to work, appropriate steps should be taken to ensure that cuts and wounds are covered with a waterproof dressing.
  • Floors should be clear of excess debris, standing water, and anything else that might harbor germs or pests.

Is Everything Tracked?

Even if your storage facility is perfect, there’s a chance that a given lot can go bad in the manufacturing or shipping process. This is when keeping adequate records is extremely important.

Tracking inventory by manufacturing lot or expiration date requires having the right kind of software. Items should be trackable at each stage, from receiving to storage to shipping.

This kind of tracking is crucially important in the case of returns or recalls on items. When looking at a facility, you should ask:

  • Can they quarantine inbound product until the appropriate inspections have been completed?
  • Can they adapt “on the fly” to requirements for FIFO or FEFO?
  • Can fulfillment for a given product or lot be immediately frozen if a problem is identified?
  • Can shipment records provide information on where specific lots have been shipped?

Don’t Phone It In

Many merchants will take the time to comply with FDA requirements in their own facilities but then fail to do their due diligence when it comes to their partners and vendors. Remember that any company with a role to play in shipping, logistics, or fulfillment also needs to meet the FDA’s requirements, if you are dealing with FDA-regulated products.

Our own company deals with such products all the time, and we have special facilities and processes to bring these capabilities to our clients. If you would like to learn more about our FDA-registered facilities, just reach out:


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Tag(s): Blog , News

April Mertens

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