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  • 1.  FDA Establishment registration - separating establishment

    Posted 12-Jun-2020 01:40
    Hello,
     
    Wanted advice for the below scenario:
     
    Company A (parent company) based overseas has a domestic subsidiary Company B. Both Company A and Company B are manufacturing facilities and marketing their products in US.
    Company A has the account with FDA as owner/ operator for the 2 establishments , Company B has the sub account .
    Due to organisational changes Company B will no longer be a subsidiary company and will be a separate establishment.
    • What are the steps in FURLS that need to take place for these changes ?
    • Establishment fees have been paid for both Companies for this financial year. With this change would it require payment of establishment fee again for Company B?
     
    Thanks & Regards,
     
    Rashmi Pillay
    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
    T + 61 8 7074 8105
    E  rpillay@ellex.com
    W ellex.com
     

     
     
     


  • 2.  RE: FDA Establishment registration - separating establishment

    Posted 13-Jun-2020 07:43
    Rashmi,

    Company A needs to update their establishment information, e.g. take of the subsidiary company.
    Company B needs to get their own FURLS account and register the establishment.

    Keep in mind, both companies need to pay the establishment fee separately now.  Yes, Company B would need to pay the fee for this year, or wait to make the change until end of the year, when the new registration fee payment is required.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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