You need to update your establishment details when this happens, not wait for the year end. Generally an update is a free but an extra establishment may be a new registration.
You need to develop a plan on logistics: how long will mail be redirected, do 800 numbers need to get switched etc and how does this line up with product life. Do you need to change boxes and inserts on long-life items? Do service engineers need to relabel equipment on annual service or repair? Do you need to update manuals? The more you look at the detail, the more complex it gets, but putting the effort to get a good plan will avoid confusing customers and regulators alike!
Good luck! It is bound to be learning experience!
Neil
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Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
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Original Message:
Sent: 14-Oct-2019 09:28
From: Gwendolyn Lohr
Subject: Corporate Office Address Change
For a medical device company in the US that changes headquarter locations, can this be an annual reportable with FDA? How much time between the location change and having to change all of your labelling to the new address?
____________________________________________
Gwendolyn Lohr
QA Regulatory & Compliance Specialist
Novo Nordisk Pharmaceutical Industries, LP
3612 Powhatan Road
Clayton NC 27527
USA
919 274 7383 (mobile)
gwwa@novonordisk.com
Driving change since 1923
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