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Inteligistics solves FSMA 204 transformation and transfer reporting problem

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Salinas, CA (February 12, 2025) — As companies that grow, manufacture, process, pack, hold or sell perishable foods on the Food Traceability List prepare for the January 25, 2026 compliance date, they are struggling to find answers for complex supply chain processes.

“It’s difficult enough to be able to report the required CTEs and KDEs within 24 hours for simple processes such as a field-pack product that goes from field to cooler to DC to store,” said Gary Fleming, Inteligistics CEO, “but when products are ‘transformed’ by value-added processing, co-mingling with other products, re-packaging, etc., the tracking and reporting complexity is amplified. Internal transfers at the supplier, distributor and distribution center adds additional challenges to managing the data.”

Transformations and transfers add to the complexity of FSMA 204 reporting because not only is each product subject to more KDEs and CTEs at each step of the supply chain, but more companies are involved, which increases the likelihood of infestation. Each step of the process (transformation) or internal movement (transfer) has not been historically tracked with a unique lot or batch number, and invoices usually don’t contain all the required information.

FSMA 204 will require new Traceability Lot Codes to track these complex transformation and transfer events, and Inteligistics’ 1-Click FSMA Report is the only solution on the market that is ready to provide Traceability Lot Code tracking and reporting for these complicated tracking CTEs today. Fleming’s broad experience in food safety, traceability, and supply chain technology enabled Inteligistics to create its innovative, 1-Click farm to store solution.

The FDA created the Requirements for Additional Traceability Records for Certain Foods to implement Section 204 of the Food Safety Modernization Act. The purpose of the rule is to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

The core of this rule is the requirement that records be maintained at each step of the supply chain where infestation could occur. These key events, called Critical Tracking Events (CTEs), along with their required Key Data Elements (KDEs), provide the information required by the FDA for a quick and thorough investigation.

This information needs to be available for subsequent recipients of your product, as well as to the FDA within 24 hours of notice. This information is usually spread across multiple data platforms and Inteligistics’ 1-Click FSMA 204 Report is the only stand-alone product that works with all existing data platforms without requiring platform upgrade or migration.

As a single product could go through multiple CTEs before it reaches the end-consumer (e.g. transformations, transfers), each CTE would need to be investigated. In a typical perishable supply chain with five to eight segments, it can take up to a week for the FDA to identify all locations of implicated product and begin recall efforts.

“Faster removal of implicated products from the system results in less sickness and death, fewer lawsuits and less damage to brand reputation,” said Lawrence Mallia, VP of Digital Transformation at Inteligistics. “Inteligistics can provide full supply chain tracking and reporting with all necessary KDEs and CTEs, from product origin to final destination in less than 60 seconds with a single click.”

For more information on Inteligistics, visit https://www.inteligistics.com.

About Inteligistics
Inteligistics is uniquely placed in perishables industries using Silicon Valley technology and process improvements to bring digital transformation, turn Big Data into clear actions through AI/ML, and deliver high value improvements to supply chain and cold chain performance for perishable commodities. The resulting increase in productivity and reduction in critical cut-to-cool times, resources help meet sustainability goals. Using IoT, off-the-shelf wireless hardware, and proprietary cloud-based applications, Inteligistics develops custom solutions and provides an end-to-end integrated supply chain platform and standalone applications that improve quality, throughput, increase profits and deliver high ROI on the critical process of moving product from field to consumer. Visit inteligistics.com and linkedin.com/company/inteligistics.

Contact:
Lawrence Mallia
(831) 233-2652
lmallia@inteligistics.com

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