Regulatory Open Forum

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  • 1.  Form 483 question

    Posted 29-Jul-2016 10:27

    Hello Everyone,

    About how long does it take for the FDA to reply to a facility's response to a Form 483? The site's aNDA is pending approval.

    Thank you,

    Sarah Green

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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  • 2.  RE: Form 483 question

    Posted 30-Jul-2016 18:16

    FDA typically does not respond to FDA-483 responses from manufacturers.  They do respond to Warning Letter responses that have been filed on time.  If they do not get a timely response from either FDA-483 or Warning Letter or they are not happy with the Warning Letter response, they may respond with a Warning Letter at some unknown time.  You can learn a lot by reading the weekly Warning Letter postings that typically are sent out in an e-mail notice on Wednesday morning.  You can subscribe to this notice.

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    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

    Original Message


  • 3.  RE: Form 483 question

    Posted 31-Jul-2016 02:07
    Although the fda is not required to respond to a 483 response, a complete response addressing all issues will go a long way towards avoiding a warning letter. I just wrote a book for barnett International on the topic of warning letters and learned a great deal about fda processes leading up to the warning letter. As you might imagine, failing to respond to the 483 issues or offering a combative response to the 483 might be more likely to receive a warning letter. Also, the process of review goes from district to center level and can go up to the office of the general council at FDA if needed. As the original question suggested, yes, the FDA does consider the 483 findings during review of open applications.

    Sent from my iPhone


    Original Message


  • 4.  RE: Form 483 question

    Posted 01-Aug-2016 17:07

    If FDA has issued you a 483, I would recommend that you address the 483. If there is anything in the 483 that you disagree with, inform FDA in writing for clarification. Implement the correction action(s) to address the "agree upon" 483. Be sure your corrective action(s) is/are documented. Keep in mind that FDA can knock on your door on any given business day that your facility is open. FDA can show up, unannounced or they can wait for you next inspection. Either way, your corrective action should be in-process or completed.

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    Ray Witherspoon
    Manager Regulatory Affairs and Quality
    ray.witherspoon@mckesson.coMemphis TN 38119

    Original Message


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