FDA Registered Facility – Only Part of the Story

Blog, News

November 9, 2015

First things first: anyone can say that they are an “FDA facility.” But if they are not registered with the FDA, and have a registration number to prove it, then they are in violation of FDA regulations.  Today it is not just the manufacturer that must be registered, but also anyone involved in the storage, order processing and shipping of certain goods and products.  So if you are involved in marketing and selling any of the following, you need all of your supply chain partners to have FDA registered facilities to ensure your product’s quality:

  •  - Specialty foods and beverages
  •  - Cosmaceuticals
  •  - Nutraceuticals and nutritional supplements
  •  - Medical supplies

When looking to engage a 3PL that will handle your storage and fulfillment needs, not only do you want to validate their FDA registration, but also make sure they are operating in compliance with CGMP guidelines. FDA regulations are pretty strict, and there are always changes being made, so make sure your business partner is up to speed. Ask yourself this – could they pass an FDA inspection and audit?

Here are just a few to consider:

FDA registered facilities need to have the right environmental conditions and controls. This might seem obvious, but there are some questionable facilities that will make promises that they can’t keep. Make sure that the facility you are considering has the right environmental controls for your product, and has back-up plans in the event of a power disruption or critical equipment failure.

FDA registered facilities need a way to track production and shipping. This requires having the right software and processes to ensure they can track your inventory by manufacturing lot or expiration date from receiving, storage, shipping, and returns. Can they quarantine inbound product until inspections have been completed, adapt on the fly to requirements for FIFO or FEFO, or have the means to immediately freeze product if a problem is identified?

FDA registered facilities must have the ability to quickly perform and track recalls. Recalls are fairly rare, but when they happen—and they do inevitably happen—your facility has to be able to respond quickly, and with full visibility.  A good 3PL will routinely perform “mock recalls” to demonstrate that they can handle a recall without incident.

FDA registered facilities need to have superior quality controls. There are requirements that an FDA facility must meet with regards to quality, sanitation and training. Dedicated teams are usually assigned to specific tasks, such as employee training, maintaining records, updating documentation, and overseeing a stringent pest control program.

All of this puts some heavy requirements on logistics providers.  Reputable ones will strive to meet all of these requirements.  If you have a delicate product, you shouldn’t settle for less.  After all, you only get one opportunity to create a lasting impression for your brand.

Materialogic has FDA registered facilities and conforms to CGMP guidelines. We would be happy to show our facilities and processes to you. Contact us for more information or to ask about our warehousing, shipping, and logistics capabilities.