FSMA 204 software with the 24-hour sortable extract ready — every KDE at every CTE for FTL items.
The FDA Food Traceability Final Rule (21 CFR 1 Subpart S) compliance date has been extended to January 20, 2028. Manufacturers, processors, packers, and holders of Food Traceability List (FTL) items must capture Key Data Elements (KDEs) at every Critical Tracking Event (CTE) — harvesting, cooling, initial packing, first receiver, shipping, receiving, transformation — and deliver a sortable electronic extract to FDA within 24 hours. Written for food companies whose current traceability lives in receiving PDFs and case-label spreadsheets.
You're shopping because the current 'traceability program' is receiving PDFs and case-label spreadsheets.
No structured KDE capture at receiving, transformation, or shipping
The traceability lot code (TLC) isn't consistently assigned or linked to inputs
First receivers for RACs can't reconstruct originator and harvest KDEs
Producing the sortable extract would take a week, not 24 hours
FTL scope for your SKUs was never formally determined
Transformation events don't link input lots to output lots in queryable form
FSMA 204, run as one traceability spine.
Traceability Lot Code (TLC) engine
TLC assigned at initial packing / first receiver / transformation, carried through every downstream CTE, and linked to inputs at every transformation.
KDE capture at every CTE
Harvesting, cooling, initial packing, first receiver, shipping, receiving, transformation — each with the specific KDEs the rule requires, no free-text drift.
Sortable electronic extract
24-hour FDA request produces the sortable spreadsheet the rule specifies — no export project, no consultant.
FTL scope determination
SKU-by-SKU FTL determination with rationale documented — leafy greens, cheeses, shell eggs, cucurbits, herbs, nut butters, RTE deli salads, all mapped.
Transformation lot linkage
Every transformation event links input TLCs to output TLC in queryable form. 'Back one, forward one' becomes 'end to end' automatically.
Supplier & customer data exchange
GS1 EPCIS + inbound/outbound KDE exchange with trading partners — inbound receiving KDEs auto-attach to inventory, outbound KDEs auto-attach to shipments.
What changes the day this goes live.
- 24-hour sortable extract is a query, not a project
- Mock recall on an FTL item completes in hours, forward and backward
- First receivers reconstruct originator and harvest KDEs from records, not phone calls
- Transformation events link inputs to outputs without spreadsheet stitching
- FDA inspector's KDE spot-check on any lot returns a complete record
The frameworks a food safety director owns.
FSMA Section 204 · 21 CFR 1 Subpart S
Food Traceability Final Rule — FTL, TLC, KDE, CTE, sortable extract obligations, extended compliance date of January 20, 2028.
21 CFR 117 (Preventive Controls)
Preventive Controls for Human Food alignment — traceability data supports recall procedures and supply-chain program under Subpart G.
GS1 EPCIS 2.0
Electronic Product Code Information Services for event-based traceability — the interoperable format most retail customers already require.
FSMA 204 software, answered.
When is FSMA 204 compliance required?
The FDA extended the compliance date to January 20, 2028 (from the original January 20, 2026). Sites should not treat this as a delay — the sortable-extract obligation and KDE capture at every CTE requires structural work that takes 12+ months to do properly.
What is a Traceability Lot Code (TLC)?
TLC is a code that identifies a specific lot of an FTL food. It's assigned at initial packing (for RACs) or at first receiving or transformation, and must be applied consistently and carried through every downstream CTE.
What's the sortable extract requirement?
On FDA request, a covered entity must produce an electronic sortable spreadsheet containing traceability information for FTL foods within 24 hours. V5 produces this as a native export against the underlying KDE/CTE data.
How does V5 handle transformations?
Transformation events link input TLCs to the output TLC in queryable form — no lot-genealogy consultants required. This makes 'back one, forward one' a full end-to-end trace automatically.
Stop treating January 2028 as far away.
Free trial. Real TLC, real KDE/CTE capture, real sortable extract.