The FDA has warned importers who rely on mail deliveries that due to reduced capacity to produce and mail hard-copy Notices of Action (“notices”), they are strongly encouraged to use the FDA Import Trade Auxiliary Communication System (ITACS).
ITACS enables electronic distribution of FDA notices, including those for exams, detentions, and sampling, eliminating delays from traditional mail. Accounts offer access to up-to-date entry status and details of information requests.
Importers can access basic ITACS functionality at https://itacs.fda.gov. To create an account, visit the FDA Unified Registration and Listing System (FURLS) at https://www.access.fda.gov/oaa. The FDA strongly urges all importers to transition to this electronic system to ensure timely receipt of critical information.