Hello Anon,
As previously stated it is important to deactivate/remove a site from the Establishment Registration with US FDA because of the potential for an inspection to be performed. When the last manufacturing is complete, then the establishment can be deactivated - if there are still remaining inventory there is not really a link between this and importation of goods. The importation of goods is more linked to the Medical Device Listing - so if this has been updated, there should not be any issue (assuming medical devices - it is slightly different with drug products). It would be highly recommended to have a Quality Plan in place described the closure of Site A and activation of Site B, what happens to the inventory, responsibilities, labelling change-over as needed, storage and handling, etc. The Quality Plan would also clearly define dates when manufacturing stopped at one site and manufacturing started at another site, because this often overlaps - with registration of the Establishment linked to these dates.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 05-Mar-2024 10:32
From: Anonymous Member
Subject: Manufacturing Site Closure - FDA Establishment Registration Question
This message was posted by a user wishing to remain anonymous
It is important to deactivate a facility that is no longer in use, so FDA doesn't try to inspect it.
https://www.access.fda.gov/drlm/help/index.html
Make sure to preserve the manufacturing records from that site.
Original Message:
Sent: 05-Mar-2024 00:17
From: Anonymous Member
Subject: Manufacturing Site Closure - FDA Establishment Registration Question
This message was posted by a user wishing to remain anonymous
Hello all,
I am working for a US company that is transferring their manufacturing from Foreign Site A to Foreign Site B and will be closing down Site A. All remaining inventory from Site A is being stored at Site B.
I have updated medical device listings to add Site B as a contract manufacturer and foreign exporter, but is it possible to deactivate the registration for Site A and continue to export remaining inventory labeled with Site A to the US? Or do I need to keep the Site A registration active in order to sell off that inventory in the US but somehow inform FDA that all records and activities are now located at Site B?
Thank you!