CBP Says FDA ITACS Users Should Submit Only Standard Entry Documentation
According to a U.S. Customs and Border Protection CSMS notice, the Food and Drug Administration asked that Import Trade Auxiliary Communication System (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.
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Additionally, entry documentation may be submitted via ITACS at the time an entry is filed, rather than waiting for a document request, said the CSMS notice. 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.