The FDA requires full compliance with 21 CFR Part 1 Subpart S, Additional Traceability Records for Certain Foods by January 20, 2026. At a minimum the new regulation requires each entity to:
Confirm which of the entities’ products are included in the FTL; Develop, maintain, and implement a written Food Traceability Plan; Define the Traceability Lot Code system that entities will apply to the food products identified on the FTL; Maintain and, in some situations, pass records containing the Key Data Elements (KDEs) for each Critical Tracking Events (CTE) identified; Share traceability records and KDE information via a Sortable Spreadsheet with the FDA within 24 hours of an official request or within some reasonable time to which the FDA agrees.
Please answer the following survey questions so we can gauge how ready your company is for FSMA 204.