Hello Rashmi,
I understand this as a Company with Corporate office at X location, having two manufacturing locations - A and B, of which A is also served as legal manufacturer for ALL products of that Company. All product labeling reflects A's address only.
If A discontinues manufacturing, A can still continue as legal manufacturer and the address can still be maintained on labeling provided there is no change to the location of records such as Technical Files, DHFs, etc..Only the operations of manufacturing records for the products manufactured at A will not be available.
When your registration certification body or notified body visits you to audit, you must ensure all records are located at A and the scope of your ISO 13485 certificate will be changed- to exclude manufacturing operations of xyz products. At the same if the products manufacturing at A are moved out to other site, the scope of that particular site will have to be changed to reflect the manufacturing of these transferred products.
Hope this helps!
Regards
Sreenu
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SATTU Sreenu
Regulatory Affairs Manager
Singapore
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Original Message:
Sent: 06-Apr-2017 19:37
From: Rashmi Pillay
Subject: Legal address
Hi,
Needed advice on the below matter:
If a Company X has a manufacturing facility at site A which is the legal address and another manufacturing facility at site B. But the operations discontinue at A and all the operations are only at B. My question is :
Whether Site A can continue to be the legal address minus operations at site, if no what are the minimum requirements to continue as a legal address?
Will the Notified body issue ISO 13485 certificate with the legal address A or address B?