Everything You Need to Build a
Traceability-Ready Operation
Guides, webinars, tools, and expert insight to help food manufacturers and distributors understand, plan, and prove FSMA 204 readiness — before it is needed.
manufacturing leaders
From Farm to Fork: FSMA 204 Traceability Across Your Network
A presentation-ready deck covering FSMA 204 requirements, CTE and KDE obligations, and how to build a traceability-ready operation before the 2028 deadline.
FSMA 204 Recall Readiness Gap Analysis
36 assessment statements across 6 critical areas. Score your current state, identify the gaps that matter most, and build a 90-day action plan before an FDA request surfaces them first.
From Farm to Fork: Building True End-to-End Traceability Under FSMA 204
A comprehensive guide to FDA food traceability regulations and how Nulogy helps organizations across the food supply chain build compliant, future-ready operations.
FSMA 204 in Practice: Building a Traceability-Ready Operation
Food safety leaders, operations teams, and technology decision-makers join this live panel to get practical guidance on meeting FSMA 204 requirements before the 2028 deadline - from experts who are working through this right now.
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
Moderated by Adrienne Blume, Editorial Director, Food Safety Magazine
Can't attend live? A recorded replay will be made available to all registrants after the session.
Meet the panelists
FSMA 204 Recall Readiness Gap Analysis
Assess your organization's FSMA 204 traceability readiness across six critical areas. Rate each statement to surface real gaps and leave with a clear picture of where to focus before the 2028 compliance deadline.
Recall Readiness
Gap Analysis
Can your organization produce complete, sortable traceability records within 24 hours — for every Food Traceability List product, at every site? This assessment helps you find out.
The FDA extended the FSMA 204 compliance deadline to July 20, 2028. The operational work — mapping CTEs, aligning KDE capture, engaging suppliers, and running mock recalls — takes 18 to 36 months for organizations starting from a low base. Starting now is not early. It is on time.
- You capture more traceability data than you can retrieve under time pressure.
- Your suppliers are at least one data maturity tier behind your internal systems.
- You have never run an unannounced mock recall with a real lot number.
Frequently Asked Questions About FSMA 204
Regulation
FSMA 204 is Section 204 of the FDA Food Safety Modernization Act. It establishes new recordkeeping requirements for companies that manufacture, process, pack, or hold foods on the Food Traceability List (FTL). Covered entities must maintain specific traceability records - called Key Data Elements (KDEs) - at defined Critical Tracking Events across the supply chain, enabling the FDA to trace a contaminated food back to its source within 24 hours. Learn more about FSMA 204 traceability.
Deadline
The FDA originally set a compliance deadline of January 20, 2026. The FDA subsequently extended the deadline to July 2028 to give the food industry additional time to build and implement compliant traceability systems. Companies are encouraged to begin building their traceability programs well ahead of the extended deadline.
Scope
FSMA 204 applies to foods on the FDA Food Traceability List (FTL), which includes high-risk commodities frequently linked to foodborne illness outbreaks. Examples include leafy greens, fresh tomatoes, peppers, cucumbers, shell eggs, nut butters, fresh herbs, finfish, and certain cheeses. If your products include any FTL ingredients - even as components in a finished good - you may have traceability obligations.
Core Concept
Critical Tracking Events (CTEs) are defined points in the food supply chain where traceability records must be created or updated. Under FSMA 204, the five CTEs are: growing, receiving, transforming, creating, and shipping. At each CTE, companies are required to record specific Key Data Elements tied to the lot or traceability lot code of the food being handled. For most food manufacturers and co-packers, the relevant CTEs are receiving, transforming, and shipping.
Core Concept
Key Data Elements (KDEs) are the specific pieces of information that must be recorded at each Critical Tracking Event. They typically include the traceability lot code, the location where the event occurred, quantity and unit of measure, date of the event, and a reference record identifier such as a Bill of Lading or purchase order number. The exact KDEs required vary by CTE and commodity type.
Core Concept
A Traceability Lot Code (TLC) is a unique identifier assigned to a specific lot of food at a particular point in the supply chain. TLCs are the connective thread across all traceability records - they allow the FDA to follow a product forward or backward through the supply chain. When a transformation event occurs (such as processing or repacking), a new TLC must be assigned to the output lot, and the input TLCs must be recorded to maintain the chain of traceability.
Applicability
Any company that manufactures, processes, packs, or holds foods on the Food Traceability List is generally required to comply, including growers, shippers, distributors, co-packers, contract manufacturers, and retailers. Exemptions exist for very small businesses meeting specific revenue thresholds, farms below certain size limits, and some retail food establishments. If your operation handles FTL foods at any point in the supply chain, review your obligations with a food safety regulatory consultant.
Nulogy
Nulogy's FSMA 204 traceability solution captures Key Data Elements at Critical Tracking Events - receiving, transforming, and shipping - within existing production workflows. It generates and maintains Traceability Lot Codes, links them across transformation events, and stores records in a format that can be retrieved and submitted to the FDA within the required 24-hour window. This means traceability is built into daily operations, rather than bolted on as a separate reporting step.
Nulogy
Yes. Nulogy is purpose-built for co-packers, contract manufacturers, and outsourced manufacturing environments. The platform captures lot-level traceability records across receiving, production, and shipping operations - linking raw material lot codes to finished goods lot codes at the point of transformation. This lot linkage is critical for meeting FSMA 204 transformation event requirements in multi-step or multi-ingredient production environments.
Nulogy
When a food on the Food Traceability List is transformed - through processing, repacking, or co-manufacturing - FSMA 204 requires companies to record which input lots were used and assign a new Traceability Lot Code to the output. Nulogy captures this linkage at the production order level, automatically connecting inbound raw material lot codes to finished goods lot codes. This creates a continuous, auditable chain of traceability from raw ingredient to shipped finished good.
Nulogy
Nulogy stores traceability records digitally and can retrieve lot-level data across receiving, production, and shipping events on demand. This supports the FDA's requirement for companies to provide records within 24 hours of a request during a foodborne illness outbreak or recall investigation - replacing manual paper searches or disconnected spreadsheet lookups that make rapid response impossible.
Nulogy
Yes. Nulogy integrates with ERP systems such as SAP and other warehouse management or supply chain platforms, enabling traceability data to flow between systems without duplication or manual re-entry. Companies can achieve FSMA 204 compliance without replacing their existing infrastructure - Nulogy fills the traceability gap at the shop floor level and feeds data upstream into existing record systems. Learn more about Nulogy's FSMA 204 solution.
See Nulogy FSMA 204 Traceability in Action
Capture CTEs, KDEs, and TLCs across your supply chain and produce FDA-ready records in under 24 hours.
Book Your FSMA 204 Demo