FSMA 204 compliance, built into how you run your business.
The FDA Food Traceability Rule compliance date is July 20, 2028 — but suppliers, labels and systems take months to align, and your retailers and distributors are already asking for traceability data. ACLN implements Odoo so lot tracking, CTE/KDE records and the FDA export become a byproduct of daily work, not a separate project.
How ready are you for FSMA 204?
Answer 9 quick questions. See your readiness score and risk tier instantly — no email required. Unlock your full action plan with your work email.
Please answer every question to see your score.
Your FSMA 204 readiness
Your action plan
Your first step is below. Unlock the rest with your work email.
Unlock your full action plan
All your next steps, emailed to you — plus the Excel traceability template. A senior ACLN consultant will follow up to help you close the gaps.
Your action plan is unlocked and on its way.
Want a human to walk you through it? Book a free, no-pressure assessment with a senior, Odoo-certified ACLN consultant, in your time zone.
Not ready to talk yet?
Start with our FDA-ready traceability spreadsheet template — an editable Excel file with the CTE/KDE columns you'll need (plus a how-to tab), ready for Excel or Google Sheets.
More time isn't less work. It's a head start you can use — or lose.
The deadline moved. The requirement didn't.
Compliance is now due July 20, 2028 — but FSMA 204 is permanent. The extension is time to get it right, not a reason to wait.
1 hour to answer the FDA.
On request, you must produce a sortable electronic spreadsheet of your traceability records (CTEs & KDEs) within 1 hour. Paper and scattered sheets don't scale to that.
Supply-chain alignment takes months.
Traceability only works end-to-end. Getting lot data flowing from every supplier, through your operation, to your customers is a multi-month effort — starting in 2028 is starting late.
Recalls & lost contracts are the real risk.
Without lot-level traceability, one contaminated ingredient means a broad, costly recall — and retailers are already dropping suppliers who can't share traceability data.
Traceability that's built in, not bolted on.
ACLN implements Odoo so FSMA 204 readiness becomes a byproduct of how you already run the business — purchasing, inventory, manufacturing, POS and sales in one system.
01Lot & batch tracking, end-to-end
Every incoming ingredient and outgoing product carries a lot/batch number automatically, from receiving to shipment — no separate logbook.
02CTEs & KDEs captured automatically
Critical Tracking Events — receiving, transformation, shipping — and their Key Data Elements are recorded as your team works, not re-keyed later.
03FEFO for perishables
First-Expired-First-Out picking for short-shelf-life, date-sensitive goods — cuts waste and keeps the freshest stock moving first.
04One-click sortable export
Produce the FDA-requestable, sortable electronic spreadsheet of CTE/KDE data in minutes — answering a 1-hour request without the fire drill.
05Single source of truth
POS, inventory and manufacturing share one database — so any finished lot links straight back to the exact supplier lots it was made from.
More than software
Odoo core + BI, RPA and AI, delivered and operated with you. The partner that stays — not a vendor that disappears after go-live.
Questions we hear every week.
What is FSMA 204?
Section 204 of the Food Safety Modernization Act led to the FDA Food Traceability Rule (21 CFR Part 1, Subpart S), finalized in November 2022. It requires anyone who manufactures, processes, packs or holds foods on the FDA Food Traceability List (FTL) to keep additional, lot-level traceability records and share them with the FDA on request.
When is the FSMA 204 compliance date?
The FDA extended the original January 20, 2026 compliance date by 30 months, to July 20, 2028. The rule's requirements did not change — only the date. Because supplier alignment and system changes take months, most operations need to start well before 2028 to be ready.
Which foods are on the Food Traceability List?
The FTL includes fresh leafy greens, tomatoes, peppers, cucumbers, melons, fresh herbs, tropical tree fruits, sprouts, fresh-cut fruits and vegetables, shell eggs, soft and fresh cheeses, nut butters, finfish, crustaceans, molluscan shellfish, and ready-to-eat deli salads. Products that contain an FTL food as an ingredient are also in scope, unless the food has been through a kill step or another exemption applies. Verify every SKU against the FDA list.
What are CTEs and KDEs?
Critical Tracking Events (CTEs) are the points where records are required: harvesting, cooling, initial packing, first land-based receiving (seafood), shipping, receiving and transformation. Key Data Elements (KDEs) are the specific data points you must capture at each CTE, built around a Traceability Lot Code (TLC). You also need a written traceability plan.
Who is exempt from FSMA 204?
The rule has partial and full exemptions — for example certain small producers and small retail food establishments, foods that receive a kill step under specified conditions, and some farm-to-consumer sales. Exemptions are narrow and fact-specific, so confirm your situation against 21 CFR Part 1, Subpart S rather than assuming you are out of scope.
Can Odoo handle FSMA 204 traceability?
Yes. Odoo tracks lots and serial numbers across purchasing, inventory, manufacturing, POS and sales, links finished lots to the ingredient lots consumed, captures data at receiving with barcode scanning, and exports traceability reports as sortable spreadsheets. ACLN configures it so your CTEs and KDEs are recorded as your team works, not re-keyed later.
Onshore quality. Nearshore team.
The seniority and standards of a US consultancy — senior, Odoo-certified talent — working your hours, at nearshore rates. Official Odoo partner since 2017, ACLN delivers complete Odoo solutions (core + BI, RPA and AI) and stays to operate them with you. The partner that stays.
Online when you are
Uruguay runs about 1–2 hours ahead of US Eastern. Real-time collaboration across the full workday — not a team you brief at night and hear back from tomorrow.
US-grade Odoo talent
Senior, Odoo-certified consultants and engineers — the seniority and standards you'd expect from a US firm, structured to deliver more value per dollar.
You'll actually understand each other
Clear English, Western business norms and the same way of working — fewer misread requirements, fewer surprises, and easy on-site visits when you want them.
High value, not a gamble
Significantly lower rates than US consultancies — without the time-zone gap, handoff lag or quality lottery of far-shore outsourcing.
Turn the 2028 deadline into your head start.
Book a free FSMA 204 Readiness Assessment with a senior ACLN consultant. We'll map your FTL products, pinpoint your gaps, and lay out a realistic Odoo roadmap — no obligation.
This page is informational and not legal or regulatory advice. Confirm your obligations against the FDA Food Traceability List and 21 CFR Part 1, Subpart S. “FTL” = foods on the FDA Food Traceability List.