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  • 1.  QSR Warning Letters

    Posted 29-Sep-2019 22:56
    I'm working on a project that involves counting the number of Warning Letters that cite one or more sections of QSR. 

    I would like to understand the change in the number of Warning Letters. Does anybody have a suggestion? 



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 2.  RE: QSR Warning Letters

    Posted 30-Sep-2019 07:43

    Dan:

     

    Regarding your project to analyze Warning Letters to device firms, the July 2019 issue of Medtech Insight contains an article addressing this point.  It includes comments delivered by FDA at a recent (June) Association of Food and Drug Officials (AFDO) meeting, citing a variety of explanations for the trend of fewer Warning Letters.

     

    Having retired from FDA in 2006 as Compliance Branch Director in the New England District of FDA (Stoneham, MA), I have always been interested in agency trends in enforcement.  I'd be happy to collaborate with you if this would be of interest to you.

     

     

    Mark Lookabaugh

    Principal Consultant

    Parexel International

    195 West Street

    Waltham, MA 02451 USA

    t  +1 860 684 1588

    m +1 860 576 5240

    mark.lookabaugh@parexel.com 

    www.parexel.com

    Parexel_1

    This communication, including any attachments, is intended only for the person or entity to which it is addressed and may contain confidential information. Any review, retransmission, distribution or other use of this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please destroy any copies, contact the sender and delete the information from any computer. Thank you.

     




    Original Message


  • 3.  RE: QSR Warning Letters

    Posted 30-Sep-2019 10:18
    I truly believe it is correlated to less inspections or more enforcement discretion being applied.

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 4.  RE: QSR Warning Letters

    Posted 01-Oct-2019 14:25
    I'm inclined to agree, Ginger.  More and more it seems to me that CDRH has all but thrown in the towel on postmarket enforcement of anything.

    Dan, I think your graph would be more informative/revealing if you also charted number of inspections.  I'm not sure what use you or others are likely to make of this information, but if you wanted to know if companies have been becoming more or less prone to having major compliance issues, or whether FDA has become more or less punitive when dealing with findings,this chart won't answer either of those questions.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 5.  RE: QSR Warning Letters

    Posted 01-Oct-2019 15:16
    Device Inspection data:



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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
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    Original Message


  • 6.  RE: QSR Warning Letters

    Posted 03-Oct-2019 10:34
    Nice data presentation, Kevin.  I'm a data junkie from way back.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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