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 med...
The Orthopedics Industry 