FSMA Rule 204 is in effect. Your QA team needs to be ready.
FDA's Food Traceability Rule requires electronic CTE records, lot-level granularity, and the ability to respond to a trace-back request within 24 hours. Foodtrce is built to make that achievable.
What the rule actually requires.
The FDA Food Traceability Rule (21 CFR Part 1, Subpart S) took effect in January 2026. Here's what companies on the Food Traceability List (FTL) must maintain:
Over 200 food categories are on the FTL — including leafy greens, fresh tomatoes, fresh peppers, melons, herbs, shell eggs, nut butters, ready-to-eat deli salads, and fresh-cut fruits and vegetables. If your products include FTL items, you're subject to the rule.
You must maintain records for each CTE: initial packing, first land-based receiver (for seafood), shipping, receiving, and transformation. Each event must capture the required Key Data Elements.
At minimum: traceability lot code, quantity, unit of measure, location description, date/time, reference document type, and reference document number. Electronic format required.
When FDA issues a trace-back request, covered entities must provide the complete trace chain within 24 hours. Foodtrce reduces that response time to under 20 minutes.
All traceability records must be retained for two years. Records must be available to FDA upon request in a sortable, searchable electronic format — not paper or spreadsheets.
Each entity in the supply chain must assign and maintain a traceability lot code for products on the FTL. The TLC must link to all required KDEs and flow through every CTE.
The FSMA 204 enforcement timeline.
Every FSMA 204 requirement, covered.
Every scan event in Foodtrce captures the traceability lot code along with all required KDEs — quantity, unit of measure, location, date/time, and reference document.
Foodtrce connects receiving, processing, packing, shipping, and receiving CTEs into a single auditable chain. No manual linking required.
All CTE/KDE records are retained electronically for the full FSMA-required two years. Immutable audit log, searchable and exportable on demand.
When FDA sends a trace-back request, your QA team can export the complete response report in under 20 minutes — well within the 24-hour window.
Is your QA team ready for the call?
Book a 30-minute demo and see how Foodtrce connects your supply chain into a FSMA 204-compliant trace system.