Hello Anon,
There are many aspects which need to be addressed by your question which can not probably be answered succinctly in a single forum post. Your questions about new labelling or new products manufactured in the new site depends much on type of product, what the labelling constitutes, shelf-life of the product, what you have in inventory, etc. etc. The strong advice I would give you is generate, establish, implement, and approve a Quality Plan which describes all of your activities. Therefore, you can do what is appropriate for your business needs, quality of the product, and management of inventory, which can all be addressed and handled using a Quality Plan. The new labelling activities, re-labelling (if needed), validations, inventory movement, manufacturing at the new site, would all be managed through the resources, timelines, and activities defined in your Quality Plan. Then following the Quality Plan, although this is not all absolutely true, in most cases the only issues you may have from regulatory perspective is not following your own plan. There are many business considerations which should be made, but at least documenting these in a quality plan would reduce regulatory exposure for actions or decisions your organisation is making.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Apr-2021 15:51
From: Anonymous Member
Subject: Site Location Move
This message was posted by a user wishing to remain anonymous
As a Class II Medical Device Manufacturer in the US, if we are changing facility locations, does all inventory in the warehouse needs to be re-worked with new labeling once we have moved? Or is there a grace period? Or can we just ensure that no newly manufactured products have the old address?