The FDA will demand a list of ALL consignees for products concerned in a recall. They have authority to do this under 21 CFR 806(c)(11) concerning information to be sent to the FDA, which states,
"The names, addresses and telephone numbers of all domestic and foreign consignees of the device and the dates and the number of devices distributed to each such consignee."
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Carroll Martin
Manager, Regulatory Affairs
US Endoscopy
Mentor OH
United States
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Original Message:
Sent: 08-04-2011 04:46
From: Martin Gabler
Subject: List of consignees during recall execution
I wonder if anyone has experienced FDA requesting a list of all consignees world-wide of a product which is subject to a recall in the US.
I heard that it was requested that the list contains full contact details for all consignees (end user or distributor) including country, account name, address, city, state, zip code, full name and phone number.
To me it would be interesting to hear on what (regulatory) basis FDA is requesting information on the world-wide distribution instead of US devices only.
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Martin Gabler
Regulatory Affairs
Radiometer Medical Aps
Copenhagen
Denmark
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