Regulatory Open Forum

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  • 1.  EIRs and FDA 483s

    Posted 19-Oct-2015 13:28


    Based on my experience as a former Compliance Officer and Compliance Branch Director at FDA, the Form FDA 483 is indeed releasable under FOIA and there is no legal obligation for the recipient to provide a response to the agency.  But this information is also publicly available from FDA.  Field Management Directive (FMD) 120 addresses both points and even explicitly refers to 483 responses as "unsolicited."  While there is no legal obligation to respond to the 483, firms rarely if ever fail to do so.

    The EIR itself will (should) be proactively provided to the inspected firm pursuant to the conditions established in FMD 145 (i.e. when regulatory action is no longer being considered).

    Field Management Directives (as well as Staff Manual Guides) can be found by searching the FDA website.

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    Mark Lookabaugh
    Principal Consultant
    PAREXEL International, LLC
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  • 2.  RE: EIRs and FDA 483s

    Posted 19-Oct-2015 13:33
    FYI:  Field Management Directive 120 Describes Policies for FDA 483s

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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