FSMA 204 Compliance
Key Benefits
- 100% FSMA Rule 204 Compliance
- 80% Labor Reduction
Data
- Case 1 arrived at Site A
- Case 1 Transformation Event at 6:00AM
Journey
From Supplier → Each Downstream Facility → Inbound at Store
Disclaimer: The figures provided are examples based on existing deployments and can be customized to meet your specific project requirements
The Problem
Effective January 20, 2026, the FDA will require grocers to provide traceability data for any food products included on the FDA Traceability List (FTL) on request. To comply, Grocers must have “accurate” critical tracking event data and chain of custody visibility on these items as they move through the supply chain.
Legacy tracking solutions can be unappealing due to cost, the requirement for physical scanning of product at each critical stage, and the added manual labor that entails. Many are reluctant to jump to implement, justifiably, because of how this impacts the bottom line. Some will ultimately risk a penalty from the FDA rather than investing in a costly traceability solution.
However, FSMA 204 compliance has benefits beyond mitigating legal and reputational risk. Amongst other upsides, it helps address the 2-3% in revenue retailers lose every year due to shrink.
The Solution
The Wiliot Ambient Data Platform mitigates these showstoppers by drawing insights from affordable Wiliot IoT Pixels embedded into shipping labels, secondary packaging, or reusable transport assets (totes, pallets, etc.).
A new kind of Radio Frequency Identifier (RFID) with much lower infrastructure and labor costs is used as the data carrier enabling a no-scan, no-labor record keeping system. Low-cost, Bluetooth-based network devices are installed strategically from supplier through your distribution centers, into transportation, and finally into your stores to energize the Wiliot IoT Pixels. In turn, the products present or passing through these “zones” relay their location and sensing data passively.
This technology is called ambient IoT and it’s part of a much bigger trend to dispense with high-cost readers designed in the previous millennium, and to move towards using the radios that surround us, Bluetooth. Now and in the future, all the Wi-Fi and cellular radios will talk direct to the low-cost tags that track the traceability lot codes that food safety systems depend on.
Traceability Lot Codes and case-level location data is passed to your traceability platforms like Trustwell FoodLogIQ and iFoodDS. The level of accuracy goes beyond what is possible with barcode and gen2 RFID scanning, which is only as reliable as the human beings holding the scanners.
Chain of custody becomes automated, and further real-time alerts can be customized to address operational anomalies; like notifying store and facility operators to any location or temperature excursions as they happen, including insights such as low-stock, mis-sorts, mis-shipments, and more.
Applying ambient IoT to automate FSMA compliance doesn’t have to be a monolithic transition. The first step is the same whatever the data carrier (barcode or gen2 RFID), agreeing the processes and data flows for upstream and downstream sharing of Key Data Elements. While you may choose to start with a manual process with higher short term labor costs, phasing in the use of ambient IoT can make the cost of the record keeping sustainable in the long term. Automation of the collecting of Shipping and Receiving Events can start at the point of receipt into your distribution centers, without needing to extend the use of IoT Pixels upstream with suppliers. Moving from assumed receipt in stores to confirmed receipt can justify the investment of in new infrastructure by lowering labor costs in the store and reducing waste.
The Difference
Wiliot’s FSMA 204 Traceability solution extends to improve overall supply chain efficiencies, eliminates labor requirements, and unlocks new insights like case-level location data - all at no added cost:
100% Critical Tracking Event Visibility within 24 hours
This data continuity from producer to store means that true Digital Product Passports are enabled for the first time, providing an all-new way to tell stories about the products you carry. While the FDA is putting mandates on traceability, customers are opting for the freshest products with their dollar.
80% Labor Reduction
Store and facility employees no longer need to manually scan-in received items to update food traceability passports, as this is now fully automated
Food Recall Execution Accuracy
Enhance safety with accurate Critical Tracking Events (CTE) that enable swift identification of affected products, while reducing waste by ensuring only compromised items are removed, leaving unaffected goods untouched
Comply with FSMA 204 guidelines, while enjoying new supply chain efficiencies and data insights, for a lower TCO than existing solutions, while non-FTL products benefit from the same Automatic Reception benefits.
Explore More Solutions
On-Shelf Availability
Track case stocking journey for accurate ready to sell inventory and stocking alerts for store associates
Shelf-Life Optimization
End-to-end time and temperature signals for each case. Enable FIFO & “First Expiry, First Out” models
Last Mile Accuracy
Track the location and temperature of deliveries on their way to their destination for improved delivery accuracy and quality
Asset-level Carbon Footprint
Automate end-to-end carbon footprint tracking and compliance, from product creation to customer delivery, with AI-driven insights and real-time provenance data
"Often referred to as the architect of FDA's Food Traceability Rule,...
I've spent much of my career in both the public and private sector trying to create greater food system transparency. Wiliot's Ambient IoT Platform is a game-changer that can help food companies go beyond mere FSMA Section 204 regulatory compliance and create additional value by creating a safer, more traceable, and sustainable food system."
Frank Yiannas, Former Deputy Commissioner, Food Policy & Response, US FDA
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