When is the right time to start preparing for the US FDA to show up at your firm for an inspection?

Any experienced regulator or regulatory affairs person will tell you should always operate like an inspection is imminent and at your doorstep. But let us be realistic, that is not going to happen anytime soon, and you will not be the first one to try it.

When it comes to predicting this great mystery of when the FDA is going to show up at your doorstep, if you figure it out, do not use this method for yourself, as soon as you get a whiff as to what’s to come, place it in a can, slap some multiple language labels on it, and sell it. I guaranteed you will make you more money selling this method, than what you are currently making. This, of course, pertains to the drug and device industries as well.

While no article is going to cover all knowledge on this subject, I, as a retired FDAer, can certainly speak on the subject of showing up unexpectedly and surprising businesses for decades. Let us be clear on one piece of advice, incase you think you are going to be the next best regulatory manager that tangled with the FDA for 10 inspections and never received a Notice of Observations, or worse a Warning Letter, they do exist, but you would have a better chance at discovering Bigfoot than becoming that regulatory manager.

In my opinion, the list of what earns you the honor of being called up for an inspection consists of mainly three categories and general preparation for them.

First category, lets start with the just plain bad luck scenario- you happen to be next one on the FDA General Field “Work Plan” list for inspections and the compliance program screams out that they have to see you. These days it rarely happens just because the FDA is overbooked. Most of the time those brave souls that don’t follow advise and do something wrong, scream out to the FDA, come have some coffee at my place as they pop up on the FDA radar. By the way, if you have seen this rare device, the FDA Radar, let me know because I need one. Unless your firm happens to be overseas, there is little time for preparation. Overseas plants receive weeks, sometimes months in advance they are going to be visited. This is due to diplomatic procedures. Whether domestic or foreign firm, you should a solid team in place well trained on the logistics of an FDA visit. You should use the FDA compliance programs to educate yourself in the inspection cycles of your industry and prepare when those time frames are due.

My second category contains firms that have not screwed up but are the subject of a recent activities pertaining to new products, pre-approvals, licenses, changes to approvals, clinical studies end-points, new canning technologies, new importing of high risk products, or you just registered to be next big Wally Mart and so on. The good thing is that most of these folks know it’s just a matter of time before the FDA comes knocking at the door expecting some free coffee. The key here to understand is that you might want to invite FDA to come by and have coffee because you have the best coffee in the industry ready for them, however, the FDA decides when they want to come to you, not the other way around. This goes without saying, you start preparing long before you send that dreadful notice to the FDA that you are very proud of your change, not after.

My third general category, is the one you don’t want to belong to, but life is life and things happen- you screwed up on what you thought was the best camo since the chameleon tuxedo. You attracted the attention of the FDA. Whether you are producing papaya or an injectable Nano-camera, we all have regulations that demand the minimum that we must adhere to. When you thought you had been exceeding them for many years, you just did not make the cut. Putting blame aside, you now have the honor of being one the brightest lights on the FDA radar. You might have gotten on the list because your customers wrote some complaints from county health departments to Med –Watch, somebody told the FDA computer what they thought of your product and what your product did and it was not good. This also goes for imports, the PREDICT system hooked up with your business details one too many times and you rose to the top of the list of those most deserving of special attention. By the way, FDA is the expert, so don’t think that if you use code words or phrases to cover screw-ups like customer replacement campaigns and free customer service with a new and improved free version will keep your staunch camo status unchecked. It does not work. Darn that FDA radar thing it detects all those cryptic emails to your customers.

You should be preparing from the second you start your Corrective Action and Preventive Action or your trending data starts to show spikes that not all is well. Or your Custom House broker calling you that they had an unexpected long talk with FDA.

Let us be fair, it can also be the fault of others in your industry, similar product or process that are now on FDA’s radar, you should also prepare for a visit. There are several other categories from those mentioned above, like the case of FDA selecting your firm as the training ground for those new generation of CSOs to learn from the elders how to do things and so on.

In the absence of FDA radar, in theory we should always be prepared for the FDA or any other regulatory agency. In practice we should clearly identify those times when we have to heighten our probabilities of having to have a full pot to serve those pesky visitors.