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  • 1.  Recalls

    This message was posted by a user wishing to remain anonymous
    Posted 10-Mar-2022 10:03
    This message was posted by a user wishing to remain anonymous

    Looking for advice:

    1) Does the FDA require a US Manufacturer to notify them of a recall for a product licensed in the US but only being recalled in Brazil?

    Thanks for any advice!

    Anon


  • 2.  RE: Recalls

    This message was posted by a user wishing to remain anonymous
    Posted 14-Mar-2022 15:40
    This message was posted by a user wishing to remain anonymous

    See this link: Chapter 7 Recall Procedures (fda.gov)

    Page 18.