Regulatory Open Forum

 View Only

  • 1.  FDA Medicla devices Establishment delisting

    Posted 19-Nov-2017 16:52

    Hi,

     

    If a manufacturer has multiple manufacturing facilities and wants to delist a facility from where he has stopped manufacturing and distribution , can he delist the facility for the FDA . Is it essential to ensure that there are no stocks in distribution that were manufactured from that facility ?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     



  • 2.  RE: FDA Medicla devices Establishment delisting

    Posted 20-Nov-2017 07:13
    Hi Rashmi,

    All of your concerns can be addressed in the FDA FURLS system.  A manufacturer can simply delete the device listings for a manufacturing facility where product is no longer being manufactured.  Similarly, if the facility is no longer producing any FDA regulated products, the facility status can be changed to no longer in operation.  Doing the latter to a facility will remove the facility from the annual registration fee list.  However, there is no refund if the facility is closed during the registration period.

    Regards,
    James




    Original Message


  • 3.  RE: FDA Medicla devices Establishment delisting

    Posted 20-Nov-2017 18:32
    We recently had this situation regarding a manufacturer in France and we are in Australia. I am not too familiar with FDA rules. However, If the EC certificate is still valid and the site has shut down, the manufactured devices can be transferred to a new facility and continue to be distributed by the new Vendor until the old EC Certificate for the shutdown facility has expired.
    Please feel free to verify with FDA.

    Regards

    Kavita



    Original Message


Related Content