Trick Question

If you get an ulcer from an FDA audit, is treatment a legitimate business expense?

Luckily, neither I – 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.

Let me give you 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 they’re you used proper design controls.

So I built and implemented a routine design controls risk management and usability system.

I spotted something completely unrelated in the corner of my eye.

“Um, what’s that over there?”

“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.

“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.

Fastest audit ever!

That’s when I earned that rave review to the left there.

But it just as well could have been an audit for:

• ISO 13485

• MDSAP

• MDR

• Internal Audits

• Supplier Audits

Still, that FDA one? I consider it my second best auditing achievement.

My first was too long for this page. Besides, I need a story for when you call me later today! 😁

+ Michelle +