21 CFR Part Part 803 Corrections - Due Diligence - Contacting MIA Consignees

Hello all,
A question on due dilligence when contacting the consignee / end user for a device under correction - how far do you need to go? When sending end users a notification of correction, it is not uncommon to have the notification returned because the facility is closed and no longer in operation. How far do we need to go in an attempt to deliver the notification? The concern is that we may end up in a maze of financials, trying to uncover where the assets went, or who owns the keys to the building. What is "enough"?

Thanks,
-Kevin

Re: 21 CFR Part Part 803 Corrections - Due Diligence - Contacting MIA Consginees

Hi Kevin,

I think showing the evidence that you tried contacting the customer three (3) times regarding your recall, would be sufficient to show the effectiveness of the recall.

Regards,
Sreenu

Re: 21 CFR Part Part 803 Corrections - Due Diligence - Contacting MIA Consginees

That has been our understanding as well - the classic "three strikes" rule. However, we make the first effort which then shows us that the customer is no longer active in the marketplace, as they are bankrupt or something similar. So we can't effectively make a second or third effort to contact that consignee.

Yet the equipment may be visible from the window or the front door, so we know it is still there. Is it expected that we somehow attempt whomever is now responsible for the facility and the items inside?