There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.
Documentation proves compliance, including when it comes to acceptance activities.
Denying the agency to inspect your facility is a violation.
Furry critters have no place in a medical device manufacturing facility.
Never downplay the importance of customer complaints.
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.