If your firm does not have an MDR procedure, FDA will find out.
How you respond to Form 483 observations matters.
Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
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.
If you’re thinking of handing unsigned documents to FDA during an inspection, think again.
No reviews of pre-market applications and no certificates to foreign governments signed—ouch!
This week’s offender was awarded nine Form 483 observations.
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.