How To Flush $400,000 Down the Drain Fighting the FDA (by Jon Speer at Greenlight Guru)
How much does it cost to address FDA 483 observation and warning letter issues?
Unless you have been through this, you probably have no idea.
Maybe you are involved with medical device product development and don’t think a FDA inspection is anything you need to be worried about.
You would be wrong.
And it might cost your company $400,000 to find out.
This is a story I recently heard from a medical device startup who lost over $400,000 dealing with the aftermath of a FDA inspection.
The $400k mistake
The medical device company had successfully raised several million dollars during four rounds of funding to design and develop a couple class II medical devices.
It took them about four years from start to launch. They needed every, single dollar raised to bring their products to market.
Success.
To establish what this company was able to do is a feat that few are actually able to accomplish.
All was good until about 18 months after their launch. This is when the FDA inspectors arrived.
Sadly, for them, they realized after the fact that ALL the issues identified by FDA could have been addressed prior...
