Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
FDA appreciates nothing more than documented evidence of compliance.
Trust, but verify, your suppliers.
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.
FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
There’s no excuse. FDA really does make it easy.
If you climb into FDA’s sandbox, be prepared to play by the rules.
A twist on the classic holiday song, complete with FDA condemnation.
Regardless, let’s look at stupidity in its highest form.
A monumental screw up, complete with bad quality, regulatory and statutory practices.