Denying the agency to inspect your facility is a violation.
Selling expired devices? Oh, no.
Furry critters have no place in a medical device manufacturing facility.
How you respond to Form 483 observations matters.
Never downplay the importance of customer complaints.
Are you performing preventive maintenance?
Have repeat observations from a previous inspection? Expect a warning letter.
An FDA inspection should never be confused with a notified body audit.
Why would a company intentionally ignore FDA and market a device that hasn’t been cleared by the agency?
An adequate structure must be in place to support a QMS.