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  • 1.  Labeling with new address

    This message was posted by a user wishing to remain anonymous
    Posted 01-Feb-2021 17:12
    This message was posted by a user wishing to remain anonymous

    We are moving our manufacturing location, projected in Q4-2021.  The phone numbers, emails and website address are not changing - only the address. We will be assembling products prior to the move that will not be sold until after the move.  Can we start labeling the product with the new address prior to the move, since the product will be sold after the move so that we don't have to re-label after the move?


  • 2.  RE: Labeling with new address

    Posted 02-Feb-2021 02:50
    Hi Anon,
    First, some questions:
    1. Do you move just the production site, or does your legal manufacturer address change as well?
    2. Where are products placed on the market? Europe, US, or somewhere else? I can only speak for the European market...The approach might be different somewhere else.
    3. What risk class is your device? In other words: is a notified Body involved?
    If you just move production, you have the inform your Notified Body (Major change in QMS). The production site must then be included in your ISO 13485 Certificate (your NB will propably audit the new site for this). Once the site is included in your certificate, you can produce there. To my understanding, you would not have to change the address on the label in this case.
    If you move the whole company, including legal manufacturer address, you have to inform your Notified Body as well. Your Certificate must be updated.

    I think changing the address prior your move is walking on a very thin line. You have to make very sure that the new devices won't be brought to market until after the move. I would not recommend it.

    Regards,

    Britta

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    Britta Cyron
    Bochum
    Germany
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  • 3.  RE: Labeling with new address

    Posted 02-Feb-2021 04:10
    Hello,

    Britta raised some good areas to review, I would just add consider having a Quality Plan which describes what you are doing, how you are doing the activities, and maybe most importantly why you are doing activities they way in which they are implemented.  Indeed you could change your address prior to the move, however, how this affects manufacturing, labelling, inventory, etc., should all be described in the Quality Plan.  When/If challenged by an external entity then you have a clearly documented process for how you made the change and more importantly the reasons and justifications for how and when you did those activities.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Labeling with new address

    This message was posted by a user wishing to remain anonymous
    Posted 02-Feb-2021 17:07
    This message was posted by a user wishing to remain anonymous

    Thank you everyone for the responses. To answer the inquiries, we are manufacturer only with 510(k)  (class II) products and no customers outside the US.  We are moving the entire facility, both office-based and production/manufacturing to a new address.  We are planning on having six months worth of inventory as of the last day in the existing office to allow for inspections/audits by FDA and other agencies.


  • 5.  RE: Labeling with new address

    Posted 03-Feb-2021 10:17
    Dear Anon,

    Having undergone a similar move several times, I agree with Richard that a Quality Plan is critical.  It allows you to have a single resource where the high level decisions and controls AND RISKS are documented.  As well, be aware that the notification to FDA may affect your inspection priority and result in seeing your district representatives sooner than expected once the move is reflected with FDA.

    With respect to your specific question when can the label be changed - it can be changed ahead of time, provided its part of a documented plan with rationale and justification documented accordingly.

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    Scott Bishop
    Houston TX
    United States
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