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  • 1.  US Agent - Sales Personnel

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2022 12:09
    This message was posted by a user wishing to remain anonymous

    I'm trying to see the cons of having one of our US sales people be a US agent to represent us, a foreign company. 

    A sales person in the US meets the FDA requirements of being a US resident and having a residence in the US so we are clear there. Any thoughts on this approach rather than an independent 3rd party being the US agent?


  • 2.  RE: US Agent - Sales Personnel

    Posted 05-Dec-2022 14:37
    Hi Anon,

    This recent thread titled 'Subsidiary as our US Agent?' may be helpful for you: https://connect.raps.org/discussion/subsidiary-asor-us-agent 



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    Sydney O'Connell
    Director of Global Representation
    Dallas TX
    United States
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    Original Message


  • 3.  RE: US Agent - Sales Personnel

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2022 15:30
    This message was posted by a user wishing to remain anonymous

    Hi Anon

    It's possible the person you choose will never have any regulatory tasks to perform except logging into the website once per year to confirm their designation. On the other hand, there could be some important communications that would need to be forwarded to you promptly. You would want to choose a sales person who would be likely to recognize the difference between official communications and spam messages, and take seriously the responsibility to handle them appropriately.
    Original Message


  • 4.  RE: US Agent - Sales Personnel

    Posted 05-Dec-2022 16:10
    A sales person/office isn't prohibited from functioning as a U.S. Agent.  But I think an important question is whether a sales person will have the qualifications or other regulatory sensitivities/prowess to properly handle and manage the challenging compliance questions that FDA can direct to the U.S. Agent.  For example, see my prior post on this.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 5.  RE: US Agent - Sales Personnel

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2022 09:42
    This message was posted by a user wishing to remain anonymous

    Thanks everyone! Very helpful advice
    Original Message


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