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  • 1.  "Hidden" facilities in DMF

    This message was posted by a user wishing to remain anonymous
    Posted 19-Aug-2019 11:38
    This message was posted by a user wishing to remain anonymous

    ​​I am doing due diligence on an ANDA that we are potentially acquiring and I came across a situation with one of the "hidden" facilities in the DMF. The facility is an analytical lab used by the DMF holder to test the drug substance. During ANDA review the FDA asked the ANDA holder to add the facility to the 356h form and the ANDA holder complied. The lab has completed self-ID for FY 2019, but it is not registered as an FDA establishment. The ANDA was approved.

    My question is... is the lab required to register as an FDA establishment? If so, do we think the FDA missed this when it approved the ANDA?

    Thanks


  • 2.  RE: "Hidden" facilities in DMF

    Posted 20-Aug-2019 11:18
    You may find the information here Link

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    Chen Fong
    Quality Engineer
    Hoover AL
    United States
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    Original Message


  • 3.  RE: "Hidden" facilities in DMF

    Posted 21-Aug-2019 09:40
    That link is for device registration.  I would refer to the guidance on drug registration. https://www.fda.gov/media/71146/download

    ------------------------------
    Christopher Smith, CQE, RAC
    Coastal Pharmaceutical Consultants, Inc.
    7950 Old River Road
    Burgaw, NC 28425, USA
    910.259.8877 (land)
    910.789.1232 (mobile)
    chrissmith@coastalpharmaconsultants.com
    ------------------------------

    Original Message


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