Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Help!  I have searched the forums and the GUDID website with no luck.  I need to update our corporate/manufacturing address in GUDID and you cannot do it directly from your account. (I tried the Labeler and Coordinator roles).  Our phone numbers, email address, etc. did not change, only our physical location. 

When I reached out to FDA, the stated that the account information is connected with your corporate DUNS number and once the DUNS account was updated, it would update the GUDID account.  This has not happened - it has been three months since we updated the DUNS account. I checked our GUDID account today and it still has the old address.  Does anyone know how to the change the address? 

Thank you.

My experience is that once DUNS is updated, then you have to actively notify FDA's UDI support group of the new address in order for FDA to update GUDID.  It's not automatic.  Specifically, notify FDA of the affected GUDID Environment, Organization DUNS, Organization Name, Organizational Address in GUDID, and the New Organizational Address.  Once FDA receives that notification, FDA will get the changes updated in your GUDID account pretty quickly (i.e., two weeks or less).

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 23-Aug-2021 14:55
From: Anonymous Member
Subject: Corporate address change in GUDID

This message was posted by a user wishing to remain anonymous

Help!  I have searched the forums and the GUDID website with no luck.  I need to update our corporate/manufacturing address in GUDID and you cannot do it directly from your account. (I tried the Labeler and Coordinator roles).  Our phone numbers, email address, etc. did not change, only our physical location.

When I reached out to FDA, the stated that the account information is connected with your corporate DUNS number and once the DUNS account was updated, it would update the GUDID account.  This has not happened - it has been three months since we updated the DUNS account. I checked our GUDID account today and it still has the old address.  Does anyone know how to the change the address?

Thank you.

Hi,

I can confirm that too, it is not clearly described in the guidance about updating the "base" information.  You indeed need to update the DUNS information first through that process, and then notify FDA.  It is not a push-pull mechanism which updates automatically, FDA needs to pull the information from DUNS and this only occurs when manually performed at the initial registration or when something has changed with company information which needs to be updated in DUNS first.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Aug-2021 15:43
From: Kevin Randall
Subject: Corporate address change in GUDID

My experience is that once DUNS is updated, then you have to actively notify FDA's UDI support group of the new address in order for FDA to update GUDID.  It's not automatic.  Specifically, notify FDA of the affected GUDID Environment, Organization DUNS, Organization Name, Organizational Address in GUDID, and the New Organizational Address.  Once FDA receives that notification, FDA will get the changes updated in your GUDID account pretty quickly (i.e., two weeks or less).

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 23-Aug-2021 14:55
From: Anonymous Member
Subject: Corporate address change in GUDID

This message was posted by a user wishing to remain anonymous

Help!  I have searched the forums and the GUDID website with no luck.  I need to update our corporate/manufacturing address in GUDID and you cannot do it directly from your account. (I tried the Labeler and Coordinator roles).  Our phone numbers, email address, etc. did not change, only our physical location.

When I reached out to FDA, the stated that the account information is connected with your corporate DUNS number and once the DUNS account was updated, it would update the GUDID account.  This has not happened - it has been three months since we updated the DUNS account. I checked our GUDID account today and it still has the old address.  Does anyone know how to the change the address?

Thank you.