4 Questions You Must Answer if You’re Doing Business with FDA-Regulated Products

Manufacturers of health and medical products know — or they quickly discover — that they need to do more than ensure that customers want their products: they must also confirm that the FDA is on board with what they do, how they do it, who they do it with, and how advertise their goods online and offline. To say that making the FDA happy is complex, time consuming and costly is an understatement.

However, you may think that since your business currently (or plans on) merely re-selling vs. manufacturing FDA-regulated products — such as medical devices, cosmetics, dietary and so on — that as far as FDA compliance is concerned, you’re in the clear, right? Well, not exactly.

According to order fulfilment company Materialogic, as a re-seller you must also comply with FDA standards with respect to your storage facility, or else risk hefty fines and what could be lasting reputation damage. Here are four questions that you need to answer in the affirmative to ensure that you don’t land on the FDA’s hit list:

1. Does your storage facility have suitable climate control?

The operative word is “suitable” — because it means different things based on various types of products. For example, some goods such as cosmetics need to be stored in the 60-degree range.

2. Does your storage facility have suitable pest control?

Depending on where your facility is located and the risks (i.e. critters) that typically habitat the area, you may need to have a wide range of rodent and insect traps, as well as screens to protect bugs from entering the facility.

3. Do you have suitable contamination prevention policies?

Your people need to be trained to ensure that your storage facility is clean and risk-free. Policies include proper hand washing, swift removal of debris or standing liquids/water, and so on. Remember, too, that it’s not enough to have suitable policies: you also need to enforce them!

4. Do you have suitable tracking mechanisms and systems in place?

The FDA insists that storage facilities can rapidly track and, if necessary, remove or quarantine products that may have been compromised during manufacturing and/or shipping.

The Bottom Line

If you answered a clear, immediate and definitive “yes” to all the above, then there’s a good chance that the FDA will register your storage facility. However, if you answered “maybe” or “no” to even a single question, then you have two options: get compliant ASAP, or outsource your storage facility to a 3PL provider that ticks all of these boxes. Don’t take chances or make assumptions — because your business’s reputation and profitability is on the line!