All equipment must be qualified and calibrated for its intended use.
If an activity is not documented, it did not happen.
Furry critters have no place in a medical device manufacturing facility.
If you climb into FDA’s sandbox, be prepared to play by the rules.
You need a management representative with oversight over medical device quality.
Perhaps the organizational soul searching should begin after receiving one Form 483.
If you haven’t made the connection yet, you’re in trouble.
It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.
Get an instant warning letter with repeat Form 483 observations.