Failure to maintain and inspect equipment can get a device establishment into big trouble.
Documented evidence of compliance is your best friend during an agency inspection.
FDA appreciates nothing more than documented evidence of compliance.
You can’t just validate processes—you have to monitor them, too.
Trust, but verify, your suppliers.
In just about any industry, this is a basic part of a quality system.
Prior to design verification of packaged products, consider the following process-related elements.
If you climb into FDA’s sandbox, be prepared to play by the rules.
Regardless, let’s look at stupidity in its highest form.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.