Regulatory Open Forum

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  • 1.  Form 483 Timeframe

    Posted 24-Feb-2014 16:44
    Dear All,

    Once a site receives a 483 and responded within the usual 15 business days, how long does it normally takes for the Agency to provide feedback as to the adequacy of the site's response? The inspection was part of an NDA, hence I presume there should be some kind of performance date. Please share your experience.

    Thank you!
    Regards,

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    Tom Namsavanh
    Manager, Regulatory Affairs and Compliance
    Intelgenx Corp.
    Saint-Laurent QC
    Canada
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  • 2.  RE:Form 483 Timeframe

    Posted 25-Feb-2014 02:04
    The agency may take weeks or months before either issuing an EIR or inform you of the inadequacy of your response. There are no fixed timelines.

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 3.  RE:Form 483 Timeframe

    Posted 26-Feb-2014 11:17
    Generally, The responses to 483s are prioritized by criticality and workload. In this case since this inspection appears to be part of an NDA review, any observations will need to be resolved prior to the action letter due date. As part of the close out of the inspection, the inspector should have communicated timing and if not, you should contact the district and the FDA division reviewing your application to also find out how the inspection impacts the review. You should be proactive in seeking a response. I would contact the project manager at the FDA and ask for help in knowing what is happening, they will be able to help as the review division and district need to coordinate on this activity since it is part of the NDA process. You don't want any surprises when the action letter is sent. Good luck, Dar ------------------------------------------- Darlene Rosario Principal Consultant RA, Quality and Compliance Velocity Consulting Ventura CA United States -------------------------------------------
    Original Message


  • 4.  RE:Form 483 Timeframe

    Posted 25-Feb-2014 05:22
    I would like to share my experience with API and product manufacturing sites in Japan.
    We received the PAI in the 4th week of October and the 1st week of November.  The response to the 483 was provided within 15 days.  We received letters confirming GMP compliance for one site on April 2.  Additional information was requiested for another site on April 3 with response deadline of 3 weeks.  The NDA was approved on PDUFA date soon after the additional information was submitted.
    Hope it helps.
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    Toru Murakumo RAC
    Group Manager
    Mitsubishi Tanabe Pharma Corporation
    Tokyo
    Japan
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    Original Message


  • 5.  RE:Form 483 Timeframe

    Posted 25-Feb-2014 07:53
    Tom -

    As mentioned below there are no fixed time-frames and responses will vary from district to district and from center to center. It can take six weeks or more to issue a warning letter when significant violations are found. If there are no significant violations the Form 483 can languish for up to a year before any EIR or close out letter is issued. Periodic communication is the best way to try and reach a faster resolution.

    Marc

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    Marc Sanchez
    Attorney and Regulatory Consultant
    Atlanta GA
    United States
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    Original Message