Regulatory Open Forum

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  • 1.  Complaint Handling Unit

    Posted 21-Feb-2020 11:57
    Reg Ex,

    I hope y'all had a good week.  I want to clarify a situation by asking for your expertise.  When is it appropriate to register a facility as a complaint handling unit versus a manufacturer?  For example, Company A is the specification developer/manufacturer but through an agreement Company B (a domestic distributor) will handle complaints and recalls.  In this example, Company A would register as a spec developer and Company B would register as a complaint handling unit.  Is this correct and does a complaint handling unit pay a fee?  Additionally, are there any second order consequences to this arrangement?

    Thank you in advance for your help.  

    William Coulston MS, PMP, RAC
    Quality & Regulatory Manager
    San Antonio TX
    United States

  • 2.  RE: Complaint Handling Unit

    Posted 21-Feb-2020 15:06
    Hi William,

    Under each listing you have to identify your activities - if company B is only maintaining complaint records then they would register as a 'Complaint File Establishment.' If company A is foreign then company B would also be an initial importer and have to identify company A in their FURLS account. Either way, both companies have to register and pay their annual fees. This is pretty helpful.

    Jeffrey Freedman
    Regulatory Affairs Specialist II
    Lowell MA
    United States

  • 3.  RE: Complaint Handling Unit

    Posted 22-Feb-2020 05:15

    I would agree if Company B is maintaining the complaint records (files) then they should register as a Complaint Handling unit.  Yes, they have to register and pay the fee.  FDA needs to understand which facilities are responsible for activities regarding the quality management system.  The other way to handle is Company B can take complaints, do investigations even, but as long as Company A has full and permanent access to the complaint records, then maybe Company B does not need to register as a complaint handling unit.  This is a little bit of a stretch if Company B is truly taking complaints and managing post market issues.  However, if there were an agreement between the two and Company A was taken full responsibility for complaint handling, then Company B would just be an outsourced process for Company A.  There are different ways to do things !

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Complaint Handling Unit

    Posted 23-Feb-2020 08:51
    Hi Richard,

    Your second choice for company A outsourcing to  B but A assuming full responsibility for complaint handling is a preferred choice. As long as A performs its appropriate oversight of B according  to the QSR then no fee on part of B or registration in my opinion.

    Robert Schiff PhD, RAC, CQA, FRAPS
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006