If you get an ulcer from an FDA audit, is treatment a legitimate business expense?
Luckily, neither I, the leanTeam – nor my clients – need know the answer.
If anything, you might need to sleep off the hangover after a night celebrating the easiest audit of your career.
Here’s an example.
“Um, what’s that?”
David’s company typically develops a medical device and sells the technology before it’s cleared for use. (A nice business model – if you can do it!)
Still, you need a proper quality management system. Suitors want assurance you used proper design controls.
So I built and implemented a routine design controls risk management and usability system. Talking with David, I spotted something completely unrelated in the corner of my eye.
“Um, what’s that over there?” I asked.
“Nothing to worry about, really,” came the reply. It was a product they hadn’t sold in years. Inventory was just sitting there in the back.
“Um, yeah. We need to worry about it,” and proceeded to explain why and how.
“Thank you but no thank you.”
Turns out, they kept their registration active for it. That means FDA can come in at any time and do an inspection.
I said, “You need a quality management system.” They replied, “Thank you but no thank you. FDA hasn’t been here, ever. And we’ve had this cleared since 2010. We’re not worried.”
(You know where this story is going, right?)
I prevailed. We set up something.
And yessiree, Bob, FDA showed up on their doorstep ten months later, right out of the blue.
Why You Need A Strong Regulatory Strategy?
First, you’re going to do regulatory something anyway. It’s unavoidable. So if you’re doing it anyway, do
it smartly. With me, with someone else. But do it smartly and in the least burdensome way. Beat your
competition while you’re at it.
Second, a strong regulatory strategy lets you:
Investors like knowing what they’re investing in.
If you can’t effectively project costs, timelines, and testing, you ain’t getting the money. Sorry about that.
Come to Arizona, buy me a glass of wine, and I’ll tell you about the clients who should have called me sooner. Because when you get caught being out of compliance, you’re already in a ditch.
I can help you out of the ditch, sure. But you’ll need shovels to cover up that huge hole. Probably a landscaper too. All could have been avoided, just sayin’.
Without a strong regulatory strategy, your submissions risk getting sucked into a bureaucratic vortex. Oh, the time wasted going back and forth for a change here, an edit there.
It adds up and pushes your launch back further and further.
Fastest audit ever!
My client raved when his FDA audit started at 9:30 a.m. and concluded 50 minutes later!
But it just as well could have been an audit for:
Still, that FDA example above? I consider it my second best auditing achievement.
My very best auditing achievement is a story. Ask me about it when we speak!