Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?
If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA.
Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.
Why should you attend : An FDA Inspection will check for Corrections and Removals during an inspection. Often Inspectors will check specific actions, since they will monitor your website and usually get a copy ...