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Invite FDA Re-inspection

  • 1.  Invite FDA Re-inspection

    Posted 27-Jan-2013 11:18
    Please share any experience you may have with inviting FDA to conduct a re-inspection at a foreign facility currently under drug import detention.  I am unaware of any particular process, other than to wait in the queue until the facility is assigned for re-inspection.  

    My client states they are ready for re-inspection, and would like to get the FDA investigator there so that they may restart the process of export to the USA.  

    Thanks for any comments, guidance, and for sharing your experiences.

    -------------------------------------------
    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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  • 2.  RE:Invite FDA Re-inspection

    Posted 27-Jan-2013 16:16
    A cautionary note -- you say that your client says they are ready for an inspection.  I would strongly recommend that, if they have not already done so, they have an independent audit done by an expert in the areas that were the subject of the prior FDA inspection -- and any crucial areas that FDA might wander into -- to truly confirm that your client is ready.

    Good luck.


    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
    F: +1 619 923 2648
    C +1 760 815 4762
    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:
    http://www.linkedin.com/in/michaelswit
    https://twitter.com/FDACounsel

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    Original Message


  • 3.  RE:Invite FDA Re-inspection

    Posted 27-Jan-2013 17:31
    Agree Michael. Do you have any information about inviting the FDA? ------------------------------------------- John Beasley RAC Founder and Senior Consultant Medtech Review, LLC Henderson NV United States -------------------------------------------
    Original Message


  • 4.  RE:Invite FDA Re-inspection

    Posted 27-Jan-2013 18:00
    John:

    I have not dealt with that issue recently.  At minimum, you could start with the inspectors that conducted the prior inspection.  However, if FDA has a formal process for this, I would have to research that as I am not familiar with it.

    Michael
    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
    F: +1 619 923 2648
    C +1 760 815 4762
    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:
    http://www.linkedin.com/in/michaelswit
    https://twitter.com/FDACounsel

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






    Original Message


  • 5.  RE:Invite FDA Re-inspection

    Posted 27-Jan-2013 23:10
    John,

    Depending upon the severity of the issues, it seems it can involve many months of waiting time.

    From what I have seen/read and also based on 483s, W/Ls, and close-outs through FOIA

    W/L and detention - re-inspection could take in 3-9 months or even longer after you are ready for re-inspection.
    Without W/L, automatic detention list (ADL) - Depending upon a situation, up to 12 months or longer.

    If you feel it is unduly delayed and if you are serving as your client's US agent, you can contact your congressman to inquire FDA about an unnecessary delay.

    A good starting point would be to talk to those who initially inspected the foreign facility and go from there.  

    Even though I don't think FDA will give a definite date for a re-inspection, your client can consider submitting all documentation addressing the issues complete and full and ASK (PETITION) the FDA to lift the import alert or detention without a re-inspection.


    -------------------------------------------------------------------
    Regulatory Doctor, Coach, Mentor, and Consultant
    www.GlobalComplianceSeminar.Com






    Original Message


  • 6.  RE:Invite FDA Re-inspection

    Posted 28-Jan-2013 12:45
    Dear John,

    We had similar issues with our overseas clients where they wanted to "invite" FDA to audit. FDA does not audit unless a review division asks them to or if there is an auditable event such as submission of an applicaiton using your site. If FDA already audited once and did not find issues worthy of sanctions, they will not audit at least for 2-3 years from the initial audit. 

    The best way is to prepare a formal response to the audit findings (483) and submit to FDA which should lead to an audit close-out letter, provided FDA is satisfied with the responses. If you do not get a response to your letter within 45 days, you can contact the auditor issuing the 483. In addition, as suggested by previous postings, have an auditor experienced in FDA audit conduct a follow-up audit to confirm the implementation of resolutions. This approach as worked well for our clients.

    Regards,

    Mukesh 

    -------------------------------------------
    Mukesh Kumar RAC, PHD
    Senior Director, Regulatory Affairs
    Amarex Clinical Research
    Montgomery Village MD
    United States
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    Original Message


  • 7.  RE:Invite FDA Re-inspection

    Posted 28-Jan-2013 12:54
    Thank you Chang and Mukesh,

    You've confirmed what I know from my own experience, knowledge, and practice.  I had hoped someone would be able to share with me a process and its consequences (whether successful or not) they used in their practice, or at least point me to a regulatory reference (either guidance or regulation).

    -------------------------------------------
    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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    Original Message


  • 8.  RE:Invite FDA Re-inspection

    Posted 28-Jan-2013 13:38
    John,

    As for guidance, please go here.  

    FYI:  Automatic detention list without an inspection is believed to be a new internal policy at FDA.

    According to your description, it is my understanding that your client has been inspected by FDA.  FDA began to detain the products.  I am not sure whether W/L was issued or in the process.  I am not sure what stage/status of communication it is between your client and the FDA.

    The beauty of this forum is that we play with limited facts/information.  So we have wild targets.  

    Please make sure your client doesn't send a documents written in a so-called love letter style, not addressing the issues.  

    ------------------------------------------------------------------
    Regulatory Doctor, Coach, Mentor, and Consultant
    www.GlobalComplianceSeminar.Com







    Original Message


  • 9.  RE:Invite FDA Re-inspection

    Posted 28-Jan-2013 14:13
    Thanks again Chang Lim.  I got a good chuckle from your comment about "Love Letter".  I, too, have had clients who wanted to send those style of letters.  

    The firm was inspected.  A WL was issued.  As mentioned in the warning letter, their products are on import detention.  The firm now wants the FDA to come (the sooner the better) and they are basically asking "how to get the FDA here now, so that we can get this import detention lifted" ... 



    -------------------------------------------
    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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    Original Message


  • 10.  RE:Invite FDA Re-inspection

    Posted 29-Jan-2013 12:08
    John,

    Assuming you have been able to stop chuckling regarding "Love Letter,"  my estimation is as follows.

    Based on (1) WL has been issued and (2) the product(s) have been detained, that is serious. 

    To answer your client's question, I would say "it may take 9-12 months if not sooner or  even longer" based on few cases that I am aware and unless FDA has been able to increase staff for the relevant roles.  

    If it takes that long, your client's best attempt to make is to address all the issues complete and full and ask the FDA to lift the import detention.   

    -------------------------------------------------------------------
    Regulatory Doctor, Coach, Mentor, and Consultant
    www.GlobalComplianceSeminar.Com







    Original Message


  • 11.  RE:Invite FDA Re-inspection

    Posted 30-Jan-2013 11:51
    John:

    This is from my earlier experience.  It has been a few years old, but I believe the principle is still the same.

    -My client received a WL.
    -We prepared response to address all the citations (including the CAPA plan) and sent on time to the FDA review team as specifid in the WL.
    -FDA reviewed the response and issued a letter stating that the CAPA needs to be confirmed by a follow-up inspection, along with EIR.
    -We made CAPAs as planed and made sure the whole quality system is ready for reinspection (make sure you confirm all with on-site audits). 
    -We sent an invitation letter to FDA compliance team (the same contact we sent the WL response) for the follow-up inspection.
    -We received the FDA follow-up inspection announcement letter in less than 2-month period.
    -We passed the follow-up inspection as expected.

    I hope this is of help to your case.  Good Luck! 

    -------------------------------------------
    Tang Peng PHD
    Director of Regulatory and Compliance
    ChemWerth, Inc.
    United States
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    Original Message