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  • 1.  NAMSA warning letter impact on submissions

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jul-2021 08:03
    This message was posted by a user wishing to remain anonymous


    Dear Community, 


    Do you know if NAMSA's warning letter was closed-out? We are thinking on using NAMSA for a 510k but the warning letter is keeping us from using this CRO. 


    Thank you, 


  • 2.  RE: NAMSA warning letter impact on submissions

    Posted 28-Jul-2021 10:30
    There is one Warning Letter posted for NAMSA.  It deals with GLP topics stemming from an inspection in November 2017.  Is this the one you are referring to?  

    Absent a closeout letter posted, you can get some clues/answers.
    • There is no closeout letter posted, but that (by itself) doesn't mean it is still "open" from FDA's perspective.  Closeouts can take some time and even longer to get posted. 
    • Looking at the listing of inspections, I do not see that one in Nov 2017 listed.  Inspections associated with Warning Letters often are not posted until the issues are closed.  Again, postings can be slow.
    • You could ask NAMSA about it.  This is definitely part of your due diligence in selecting them as a vendor.

    Am interested to hear from others who may have more clues or suggestions!

    Cheers,
    Melissa


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    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


  • 3.  RE: NAMSA warning letter impact on submissions

    Posted 28-Jul-2021 11:22
    Not directly related, but NAMSA was just granted ASCA accreditation for biocompatibility testing, and is the first lab for this accreditation.

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    Corey Jaseph RAC
    Director of Regulatory Affairs
    Wheatland CA
    United States
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    Original Message


  • 4.  RE: NAMSA warning letter impact on submissions

    Posted 29-Jul-2021 08:36
    Yes NAMSA got that a while ago. .Multiple labs here in the Twin Cities did except Surpass, which was just about the end the business, but never got one.  Full disclosure,  I was RA director there 2006-2008 and have a soft spot for them and their memory.


    NAMSA and American Preclinical Services got warning letters for really poor QA practices on GLP studies.   NAMSA must have cleaned up their act significantly to somehow become "FDA Certified".  

    Just shows again how the poor quality folks take the brunt of the hit when management pooh poohs it.  Typically, it is lack of QA resources or not hiring people excited about Quality and  not recognizing or rewarding them when they save the company.  

    I truly appreciate the often thankless job good quality people do.   Keep up the good work you guys!!!!



    ------------------------------
    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


  • 5.  RE: NAMSA warning letter impact on submissions

    Posted 05-Aug-2021 14:32

    As has been noted previously, NAMSA did receive a warning letter from FDA in November 2017.  That letter was relevant to a single NAMSA laboratory and was related to GLP nonconformities.  The issues did not impact any FDA submissions and did not have any relation to consulting services, clinical services or other NAMSA laboratories.  These other services are audited by FDA and other regulatory bodies separately and have not been the subject of any warning letters.  The laboratory affected did adequately address FDA's concerns and FDA was in agreement with our corrective actions. No closeout was completed by FDA on this warning letter as the laboratory has since been closed.

     

    Please feel free to reach out to me if you would like further information.



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    Dennis Crane
    Director, Regional Consulting Services
    the3cranes@comcast.net
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    Original Message


  • 6.  RE: NAMSA warning letter impact on submissions

    Posted 05-Aug-2021 14:36
    My default signature line did not work correctly, as it left out my company line and used my home email. I work for NAMSA and am based out of Minneapolis.  The best way to contact me is with my work email:  dcrane@namsa.com.

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    Dennis Crane
    Director, Regional Consulting Services
    NAMSA
    Minneapolis, MN
    dcrane@namsa.com
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    Original Message


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