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Track & Trace

Food traceability software for FSMA 204

Food traceability software records every lot you receive, transform and ship, links each one by lot code to its source and its customer, and produces the records the FDA asks for under FSMA 204. Nulogy Track & Trace builds that record from the events already flowing through your ERP, WMS and shop floor, then exports the FDA’s 24-hour sortable spreadsheet in minutes.

  • Every shipping, receiving, and transformation event in one register, searchable by lot code, product, supplier, or customer

  • Traceability Lot Codes (TLCs) generated and linked automatically, with full many-to-many genealogy when lots are combined or repacked

  • The FDA’s 24-hour sortable spreadsheet for any lot, product, date range, or partner, exported on demand

See Nulogy Track & Trace in action

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Sysco
Arrabawn
Mars
Louisiana Fish Fry
Cranswick
CAP
HelloFresh
Bushmills
Henderson
Crescent
MSI
Sysco
Arrabawn
Mars
Louisiana Fish Fry
Cranswick
Sysco
Arrabawn
Mars
Louisiana Fish Fry
Cranswick
CAP
HelloFresh
Bushmills
Henderson
Crescent
MSI
Sysco
Arrabawn
Mars
Louisiana Fish Fry
Cranswick
The 24-Hour Test

In a recall, the FDA gives you 24 hours

Not 24 hours to start looking. 24 hours to hand over complete, sortable, lot-level records for a food on the FDA's Food Traceability List. Almost no operation can do that today without food traceability software, working from spreadsheets, ERP extracts, and email threads with suppliers.

24 hrs FDA Response Window All records, on request, in a sortable electronic spreadsheet
7 Critical Tracking Events Harvest, cool, initial pack, first land receiving, ship, receive, transform
16 FTL Food Categories Leafy greens and fresh-cut produce through soft cheeses, shell eggs, nut butters, seafood, and deli salads
2 yrs Record Retention Across every covered event, plus a written traceability plan the FDA can inspect

Today, could you produce a sortable, lot-level record across your suppliers within 24 hours? If you hesitated, that is the gap. It is also the whole project. Find yours with the FSMA 204 Recall Readiness Gap Analysis.

The Language of FSMA 204

What FSMA 204 actually requires

The FDA Food Traceability Final Rule adds four things to your recordkeeping. None of them change how you make food. All of them change what you have to be able to prove, and how fast.

TLC

Traceability Lot Code

A unique identifier assigned to a batch of food, created once at initial packing or at transformation, then carried by everyone downstream.

In plain terms: the baton. Someone creates it, and every handler after them passes the same one along.

CTE

Critical Tracking Events

The seven points where records must be captured: harvesting, cooling, initial packing, first land receiving, shipping, receiving, and transformation.

In plain terms: the moments that count. Most mid-chain companies own shipping, receiving, and transformation.

KDE

Key Data Elements

The fields recorded at each event: traceability lot code, product description, quantity, the location it came from and went to, the date, and a reference document.

In plain terms: the actual columns. Miss one and the record does not satisfy a request.

Plan

Traceability plan

A written, FDA-inspectable document covering your procedures, how you identify Food Traceability List products, how your lot codes are assigned, and who to contact.

In plain terms: show your work. It is mandatory whether or not you are ever asked for records.

Two rules that decide whether you are covered. A product is covered if it contains a food from the FDA's Food Traceability List in its listed form, so fresh-cut leafy greens inside a salad kit are in scope. A kill step such as cooking or pasteurization generally ends coverage. USDA-regulated meat and poultry, previously frozen produce, and hard cheeses are outside the list.

The Rule in One Idea

Trace one up, one back: how food traceability actually works

FSMA 204 sounds like it asks you to map the entire supply chain. It does not. You are responsible for your immediate source and your immediate recipient, tied together by a lot code. Our complete guide to how food traceability works walks through receiving, production, and shipping step by step.

One Step Back Your Supplier Who you received it from, and the lot code they sent
You Internal Trace Any covered handler: manufacturer, co-packer, distributor, retail DC
One Step Forward Your Customer Who you shipped it to, carrying the same lot code
Recorded at every shipping and receiving event
Traceability lot code Product description Quantity Location from Location to Date Reference document

You never see the whole chain. You see your two neighbors. Everyone's one up, one back links into a full trace. It is more lot-tracking data, not a new way of operating. The hard part is not the concept. It is producing it, sorted and complete, in 24 hours. See how Track & Trace assembles the record →

How It Works

How Track & Trace assembles your food traceability records

Most traceability projects fail at assembly. The data exists, scattered across an ERP, a warehouse system, a shop floor terminal, and a supplier's inbox, and somebody has to stitch it into one record while the clock runs. Track & Trace is food traceability software that captures each event where it happens and links it by lot code, so the record is already built before anyone asks for it.

1 The Register

Every event in one searchable place

Harvesting, cooling, initial packing, first land receiving, shipping, receiving, and transformation all land in a single CTE register. Filter by event type, traceability lot code, source, or asset, and open any event to see the full set of key data elements behind it.

  • Search by lot code, product, supplier, customer, or date range
  • Every record carries its source location, business address, and contact
  • Trace forward to customers or back to suppliers from any single event
Nulogy Track and Trace CTE register listing critical tracking events by type, traceability lot code, source, and business address The CTE register, filtered by event type and lot code.
2 The Capture

Records created where the work happens

Key data elements are captured once, at the source, by the people already doing the work. Events arrive from your ERP, warehouse system, and shop floor through Nulogy Connect, or from a mobile check on the floor, alongside the rest of your food safety and quality assurance records. Nobody re-keys a lot code into a spreadsheet at the end of a shift.

  • Templates for each critical tracking event, so records come in complete
  • The FDA Food Traceability List and your logged exemptions, built in
  • Mobile capture on the floor, with open items visible before they age
Nulogy Track and Trace home dashboard with active recalls, CTE activity, and recent FSMA 204 assessments for shipping, receiving, cooling, and harvesting The dashboard, with the Food Traceability List, templates, exemptions, and open assessments in one view.

Then the 24-hour test becomes an export

Produce the FDA's sortable electronic spreadsheet for any lot, product, date range, or trading partner, in minutes rather than days. Same records, same register, no scramble across systems and no one working a weekend to assemble it.

Request a Demo
Where Traceability Breaks

Transformation events: lot codes and genealogy

A lot code rides untouched down the chain until the food is transformed. Repack romaine into salad bowls and the lot forks: one new output lot that has to link back to every input lot that went into it. Multiply that across suppliers, shifts, and sites, and tracing it in 24 hours is where most systems quietly give up. This is the workflow Track & Trace was built around, inside Nulogy Quality & Compliance.

One transformation event, many-to-many lot genealogy
TLC-PAK-2026…044 300 cases romaine
TLC-FLR-2026…009 450 lbs cod
Transformation New lot code assigned, both inputs linked
TLC-TRN-2026…882 1,200 salad bowls

Break either link and the trace dies. Trace forward from the romaine and you need every finished bowl it reached. Trace back from a customer complaint and you need every input lot in that bowl, including the one from a supplier who sent a spreadsheet. That upstream half is what Supplier Compliance Management closes.

Transformation critical tracking event in Nulogy Track and Trace, linking two input traceability lot codes to a single output lot with key data elements A transformation event in the CTE register: two input lots resolve into one output lot, with the output product, facility, transform date, and quantity recorded against it.

Lot codes generated for you

Track & Trace assigns the new traceability lot code at transformation and links it to every input lot automatically. No manual mapping table, no naming conventions to police.

Genealogy both directions

Trace forward from any input lot to every product it became, or back from any finished lot to everything that went into it, in one query.

Precise recall scope

Quarantine the lots actually affected instead of pulling a whole product line, so a recall stays as small as the evidence allows.

See It on Your Own Lots Or start with the FSMA 204 resource hub →
On-Demand Webinar

FSMA 204 in practice: building a traceability-ready operation

Food safety leaders, operations teams, and technology decision-makers joined this panel for practical guidance on meeting FSMA 204 requirements before the 2028 deadline, from experts who are working through it right now. The full session is available to watch.

What you'll take away

  • How to scope your FSMA 204 obligations and identify which records and systems need to change
  • What Critical Tracking Events and Key Data Elements actually look like in practice across growing, processing, and distribution
  • How to assess supplier readiness and close traceability gaps upstream
  • What a 24-hour FDA recall response requires, and how to test your operation before you're asked
60 minutes
Free · Watch anytime

Moderated by Adrienne Blume, Editorial Director, Food Safety Magazine

Hosted by

Meet the panelists

Kevin Donaghy Kevin Donaghy

Chief Innovation Officer, Quality & Compliance

Nulogy

Joe Buckley Joe Buckley

Director, Food Safety & Quality Assurance

Sysco

Bill Bremer Bill Bremer

Food & Beverage Regulatory Consultant

Independent

FSMA 204 in Practice: Building a Traceability-Ready Operation, a Food Safety Magazine webinar Watch On Demand

Watch it now

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We'll email you the link as well, so you can come back to it or pass it to your team.

FSMA 204 Questions

FSMA 204 software and food traceability, answered

What is FSMA 204 compliance software?
FSMA 204 compliance software captures the Key Data Elements at each Critical Tracking Event for foods on the Food Traceability List, links lots by Traceability Lot Code, and produces the FDA's electronic sortable spreadsheet within 24 hours of a request. Track & Trace does this from the receiving, production and shipping events you already record, so nobody re-keys lot codes into a separate system.

How does lot code tracking work for FSMA 204?
Every time you create or transform a food on the list, it gets a Traceability Lot Code. Track & Trace generates the code, records which input lots went into it, and carries it forward on every shipment. When you search a lot code, you see one step back to the source and one step forward to every customer that received it.

What is food traceability software?
Food traceability software records where every ingredient and lot comes from and where it goes, one step up and one step back, from receiving through production to dispatch. For FSMA 204 it captures the Key Data Elements at each Critical Tracking Event, so you can trace any affected lot and produce records for the FDA on request. Nulogy Track & Trace is food traceability software built for FSMA 204 compliance.

What is FSMA 204 and who has to comply?
FSMA 204, the FDA Food Traceability Final Rule, requires anyone who manufactures, processes, packs, or holds a food on the Food Traceability List to keep additional traceability records. It applies across the supply chain, so growers, processors, manufacturers, co-packers, distributors, importers, third-party logistics providers, and retailers can all be in scope.

When is the FSMA 204 compliance deadline?
The FDA extended the FSMA 204 compliance date to July 20, 2028. Buyer mandates arrive earlier: Walmart and Albertsons traceability requirements took effect in August 2025, and Sysco has targeted the end of 2026 for its suppliers. Because building lot-level traceability across a supplier network takes years, most food and beverage manufacturers are starting now rather than waiting for the FDA date.

Which foods are covered by FSMA 204?
Foods on the FDA's Food Traceability List, which covers 16 categories including fresh and fresh-cut produce such as leafy greens, melons, peppers, tomatoes and tropical tree fruits, soft and fresh cheeses, chicken shell eggs, nut butters, finfish and shellfish, and refrigerated ready-to-eat deli salads. A product is also covered if it contains a listed food in its listed form, so fresh-cut leafy greens inside a salad kit are in scope.

Does a kill step exempt my product from FSMA 204?
Generally yes. A kill step such as cooking or pasteurization applied to a listed food usually ends coverage for that product. Other common exclusions: USDA-regulated meat and poultry, previously frozen produce, hard cheeses, and catfish. Partial coverage is still common, so it is worth checking product by product rather than assuming a single answer for the whole plant.

What are Critical Tracking Events and Key Data Elements?
Critical Tracking Events (CTEs) are the seven points where FSMA 204 requires records: harvesting, cooling, initial packing, first land receiving, shipping, receiving, and transformation. Key Data Elements (KDEs) are the fields captured at each event, including the Traceability Lot Code, product description, quantity, the locations it came from and went to, the date, and a reference document. Most mid-chain companies own shipping, receiving, and transformation.

What is a Traceability Lot Code?
A Traceability Lot Code (TLC) is the unique identifier assigned to a batch of food, created once at initial packing or at transformation and then carried by everyone downstream. It is the thread that ties records together across companies. When food is transformed, a new lot code is assigned and must link back to every input lot that went into it.

How long do FSMA 204 records have to be kept, and how fast must they be produced?
Records must be retained for two years. During an outbreak, recall, or other threat to public health, the FDA can request them and expects a sortable electronic spreadsheet covering the relevant records within 24 hours. That 24-hour window, not the recordkeeping itself, is what most operations fail today.

Can I meet FSMA 204 with spreadsheets or my existing ERP?
Spreadsheets and ERP extracts hold fragments. FSMA 204 needs lot-level records linked across events, systems, and trading partners, then produced sorted and complete within 24 hours. An ERP or warehouse system is a system of record for transactions, not for lot genealogy through transformation. Track & Trace sits on top of the systems you already run rather than replacing them.

How does Nulogy Track & Trace support FSMA 204 compliance?
Nulogy Track & Trace captures Critical Tracking Events and Key Data Elements as product moves, links lots through transformation with a Traceability Lot Code, maintains a searchable register of every event, and produces the sortable electronic spreadsheet the FDA requests inside the 24-hour window. It is part of Nulogy Quality & Compliance, so traceability sits alongside your quality checks, audits, and non-conformance workflows rather than in a separate system.

Do my suppliers need to participate?
Yes. One up, one back only works when your suppliers send the right Key Data Elements, and most traceability gaps sit in the handoffs rather than inside the plant. Supplier Compliance Management handles supplier onboarding and document collection, so the upstream half of the record arrives in a usable form. If you're a distributor or retailer managing hundreds of suppliers' records, pair Track & Trace with supplier compliance software to collect and check their documents.

What is track and trace software?
Track and trace software records the movement of goods through a supply chain so any unit can be located forward or backward from any point. In food, that means lot-level records at each handoff, which is exactly what FSMA 204 requires. Nulogy Track & Trace is track and trace software scoped to the FSMA 204 use case rather than a general-purpose logistics tracker.

Why is food traceability important?
Because when something goes wrong, the size of the problem is decided by how precisely you can trace it. Good lot-level traceability turns a recall from a product-line-wide write-off into a specific set of lots, protects shelf trust with retail buyers, and satisfies both FSMA 204 and the contractual mandates that large distributors and retailers now pass down to suppliers.

What are the penalties for not complying with FSMA 204?
The FDA treats missing traceability records as a violation of the Federal Food, Drug, and Cosmetic Act, which can lead to warning letters, refusal of imported shipments, injunctions, and in serious cases seizure or prosecution. In practice the commercial consequence usually arrives first: large buyers are writing traceability into supply agreements, so failing an audit can cost the contract well before the FDA gets involved.

Who uses food traceability software?
Anyone who handles a food on the FDA's Food Traceability List: processors, manufacturers, co-packers, and food service distributors. For a distributor the job is the middle of the chain. You record receiving and shipping for every listed product, carry the supplier's lot code through to each customer delivery, and assign a new one when you repack. Large distributors are also passing traceability requirements down to their own suppliers, and Sysco has targeted the end of 2026 for its suppliers.

How do I choose food traceability software?
Start with the 24-hour test. Pick a finished lot and ask each vendor to show, live, every input lot in it, the supplier records behind each one, and every customer who received it. Then check how lot codes link through transformation, how supplier data arrives, and whether the software sits on top of your ERP and WMS. Our buyer's checklist for comparing traceability vendors covers the full criteria, and our 2026 comparison of the best food traceability software puts the main platforms side by side.

Where do I start with FSMA 204?
Start by scoping which of your products are covered and whether your current records could survive a 24-hour request. The FSMA 204 resource hub has a Recall Readiness Gap Analysis that walks 36 items across six areas in about six minutes and tells you where the gaps are.
Food Traceability Software

See your food traceability software demo

Get a personalized walkthrough of how Nulogy helps food and beverage teams trace every lot, meet FSMA 204, and prove recall readiness across every site and standard.

A global food distributor runs food safety and quality oversight across more than 180 sites on Nulogy, with the FSQA director stating: "Real-time data allows us to provide instant feedback on both food safety and quality, while audit preparation is now effortless. No more scrambling for documents."

See Track and Trace in Action
FSMA 204 Ready Built for Food and Beverage Personalized Product Walkthrough