CSMS# 12-000135 - FDA requests ITACS submission of ONLY standard entry documentation
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04/16/2012 11:55 AM EDT
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FDA asks that ITACS users submit only standard entry documentation (CF3461, Invoice, Packing List, etc.) through ITACS at this time. Compliance documentation such as private lab submissions, reconditioning proposals, extension requests and copies of labeling should continue to be submitted through traditional means until we can resolve a document retrieval issue on our side.
Additionally, we would like to advise filers that entry documentation may be submitted via ITACS at the time an entry is filed, rather than waiting for a document request. Doing so may assist our staff in reviewing entries in a timely manner.
Please send any questions about this message or ITACS to itacssupport@fda.hhs.gov
Related CSMS No. 12-000089
FDA asks that ITACS users submit only standard entry documentation (CF3461, Invoice, Packing List, etc.) through ITACS at this time. Compliance documentation such as private lab submissions, reconditioning proposals, extension requests and copies of labeling should continue to be submitted through traditional means until we can resolve a document retrieval issue on our side.
Additionally, we would like to advise filers that entry documentation may be submitted via ITACS at the time an entry is filed, rather than waiting for a document request. Doing so may assist our staff in reviewing entries in a timely manner.
Please send any questions about this message or ITACS to itacssupport@fda.hhs.gov
Related CSMS No. 12-000089
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