CSMS# 15-000132 - Problems with FDA’s ITACS System

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02/26/2015 11:19 AM EST

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FDA is continuing to receive and investigate reports of multiple issues with ITACS.



There are 4 different scenarios being investigated:



1- Document uploads made via ITACS not completing successfully despite a confirmation email being sent by the system. In these cases, nothing was uploaded to the FDA server. When this occurs, the ITACS status does not update to “Document Submitted”.



2- Document uploads made via ITACS not completing successfully despite a confirmation email being sent by the system. In these cases, the documents made it to the server, but are not visible by FDA. When this occurs, the ITACS status does not update to “Document Submitted”.



3- Complete failure of document upload function. No confirmation sent or document uploaded. When this occurs, the ITACS status does not update to “Document Submitted”.



4- Submission of Examination Availability information is not properly uploading despite the user receiving confirmation. When this occurs, the ITACS status will not update to “Line Availability Received”.



The only workaround at this time is to try resubmitting documents/availability information via ITACS (which does not guarantee successful upload) or to submit documents/availability to your FDA office via alternate means.



A listing of all FDA Import Office Locations and Contact Information can be found at the link http://www.fda.gov/forindustry/importprogram/ucm319216.htm



If problems are still encountered, or if you have any questions, please contact itacssupport@fda.hhs.gov . We understand the inconvenience of this issue and thank you for your patience as we pursue a solution. A follow-up message will be sent when the issue is resolved.