FDA Recommends Use of ITACS

CSMS #42253103 was issued advising that the FDA Recommends Use of ITACS During COVID-19 Outbreak.  Previously, CSMS #42118616 was issued advising the trade that FDA’s Import Operations remain operational, inclusive of FDA Prior Notice review, FDA entry processing, FDA sampling/examination of high risk shipments, FSVP inspections, filer assessments, and compliance activities.  However, the mailing of “Notices of FDA Action” hardcopies will be delayed. In this message, the FDA also strongly encouraged importers of food to utilize the ITACS system.

If you are an importer of food, and you do not have an ITACS account, it can be requested through the FDA Unified Registration and Listing System.  Instructions for registration are provided in the ITACS Account Management presentation.  Leveraging this technology will allow your company to have direct access to notices of action after they are issued as well as status updates on FDA holds.