Regulatory Open Forum

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  • 1.  CDRH Inspections Database Temporarily Unavailable?

    Posted 27-Oct-2015 12:12


    "The Inspections Database is temporarily unavailable while we standardize our internal processes to improve data quality."

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/inspect.cfm

    I didn't make a note of the date that I first discovered this, but it was weeks, not days ago.  There is a link beneath this statement to "Learn more....," but I didn't learn anything more about it from the information associated with the link.

    Does anyone have any information on the status of the database?  When did it first become temporarily available?  Has FDA issued any information regarding its plans for or progress in making the database available again?

     

     

     

     

     

     

     

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    Julie Omohundro RAC
    Durham NC
    United States
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  • 2.  RE: CDRH Inspections Database Temporarily Unavailable?

    Posted 27-Oct-2015 12:22
    Julie,

    When we were checking the database for few items relating to inspections in comparison with EIRs, it was working on August 21, 2015.


    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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  • 3.  RE: CDRH Inspections Database Temporarily Unavailable?

    Posted 27-Oct-2015 13:15


    Thanks, David.  I am worried about how long "temporarily" might be.

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    Julie Omohundro RAC
    Durham NC
    United States