Considering rump injections? Head to the donut shop instead.
Don’t overlook this critical practice.
You don’t need to tell FDA all the gory details.
This week’s offenders are charged with smuggling and unlawful use of silicone, injecting it straight into the buttocks.
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?