Tag Archives: FDA Inspections

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

What To Expect When Expecting

By Shawn K. Stevens
No Comments
Shawn K. Stevens, Food Industry Counsel

Childbirth and FDA inspections have a lot in common. Both are, in their most basic form, a natural part of life, both can be exceptionally strenuous while occurring and both, when finished, typically result in the highest form of extreme happiness and joy. But, more on that in a moment.

With the recent arrival of the Food Safety Modernization Act (FSMA), Congress has tasked FDA with the enormous responsibility of substantially improving the overall safety of our national food supply. To accomplish this goal, the new law imposes significant new legal (and, by extension) regulatory requirements on the food industry, and gives FDA a wide-range of incredible new powers and authority to enforce the new standards.  In turn, FDA will begin using those new powers in future food safety inspections to ensure that all food companies have implemented comprehensive, science-based written food safety plans, and have satisfied the long list of additional new mandates.

So, what can we expect when expecting?

Well, there is a great deal of apprehension in the industry. We all know that FDA is coming, but many companies are not quite sure what will happen when FDA finally arrives. Not a single company has yet to experience its first “FSMA inspection” and, as a result, the industry is, in part, begging for some help on how to better prepare for the arrival of this new, perhaps life-changing, event.  

We are here to help.

The first, and most important, step in getting ready for your first FSMA inspection is appropriately managing the broad range of emotions you will likely feel. Rather than being apprehensive, or resisting the inevitable, I recommend that my clients “embrace” the inescapable conclusion that FDA is coming to their facility. Like childbirth, the presence of FDA is now, or will soon become, and integral a part of their life. And, whether they like it or not, they have to prepare.

The second thing I tell my clients is that it’s okay to be at least a little apprehensive. It’s okay not to know what to expect. And, we’re here to help on that front too.

We understand, of course, that an FDA inspection can be a long and laborious process. For some, it will be downright excruciating. For others, it will instill a complete and total sense of helplessness.  

Although we all anticipate and hope that the process will end quickly and without complication, sometimes things can and will go wrong. There may be yelling, and we may even be asked, when things become really tense, to control our breathing. And, of course, sometimes, the process takes longer than we expected, and sometimes emergencies will happen. In these cases, stress builds, apprehension grows and panic, even if only briefly, may set in. Before it is over, you might even experience some chaos and, perhaps, a bit of confusion.

But, eventually, the tension subdues. And, like the incredible and indescribable joy and adulation that accompanies the arrival of a new life, so too is the overwhelming happiness that exists when the FDA compliance officers leave your facility — and are walking to their cars.

So, the first and most important lesson to master when you are truly “expecting” is to embrace the process, understand that it is a fact of life, know that it will eventually happen, and that it’s okay to be just a little bit scared. The second lesson you should embrace is to begin planning for the arrival of that inevitable day now. And, we stand ready to help there too.

In our next post, we will begin to explore why FDA is coming, and what FDA will “expect” when it arrives.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

When FDA Comes Knocking…

By Shawn K. Stevens
No Comments
Shawn K. Stevens, Food Industry Counsel

When you made the decision to work in the food industry, you also agreed to shoulder the incredible and important responsibility of feeding a nation. Put another way, you have given your own personal commitment, on a daily basis, to ensure that the food you are producing is as safe and wholesome as it can be.

In addition to this tremendous commitment and responsibility, you also agreed, whether you like it or not, to subject yourself to intense regulation and oversight by the U.S. Food and Drug Agency (“FDA”). Thus, if you have not yet had the opportunity to become intimately familiar with FDA, chances are that in the coming months and years, you will. Put simply, FDA is coming.

So, what does that mean?  That . . . “they’re coming…”

As you might recall, the phrase began its life as a line in a very scary 1982 movie called Poltergeist. And, in many respects, it encompasses what we are (or, will be) experiencing in the future as a regulated industry with the FDA in our mirror.

With food safety awareness increasing nationally among consumers and the media, and with the recent passage of the FDA’s Food Safety Modernization Act, FDA has been directed (and has consequently pledged) to begin inspecting food processors more often, more closely and more intimately. For this reason, whether you like it or not, you need to embrace the fact that in the coming months and years you will be closely … well, “haunted” by FDA.

Now that we have established that FDA is coming, what can (or should) we do about it? Well, just like in Poltergeist, locking the doors won’t help. Neither will closing the widows, dropping the shades, or completely ignoring the problem. And, no matter what, don’t go into the basement.

But, there are a number of things that can (and should) be done. Understanding that your next FDA inspection is unavoidable, and it will happen, it is absolutely critical to begin a dialogue today on what to expect, and how you should react, when it does.

Thus, in the following series of coming posts, we will walk you through the FDA inspection process, help you understand what to expect when it occurs, and give you advice on how to best respond.  We will examine closely the reasons why FDA may visit your facility, the purposes for which it is there, the things it will expect to see, and what you should be doing now to get ready.

Although some may consider this a “ghost” of challenge, we hope that we can provide greater transparency to FDA inspection process. With a little help, and some basic planning, there is no doubt in my mind you will survive.