De la granja a la mesa: cómo establecer una verdadera trazabilidad de principio a fin en el marco de la norma 204 de la FSMA
A comprehensive guide to FDA food traceability regulations and how Nulogy helps build compliant, future-ready operations.
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A guide for every stage of traceability readiness
This guide is designed for organizations across the food supply chain, at any stage of their traceability journey, whether you're exploring your first solution or looking to move beyond manual, paper-based processes toward a scalable, digital approach.
When implemented effectively, traceability goes far beyond compliance. It strengthens food safety, accelerates and simplifies recall readiness, and provides real-time visibility across your operations.
More importantly, it opens the door to improve plant performance, build stronger supplier relationships, protect your brand, and support long-term growth.
Download our FSMA 204 Guidance Booklet to get all the information you need to take your next steps with confidence and maintain compliance.
FSMA 204, by the numbers
Four terms worth knowing before you dig in
Trazabilidad: código de lote
A unique identifier assigned to a lot of food at the point it's created or transformed, used to link every downstream record back to that lot.
Critical Tracking Event
A point in the supply chain, such as receiving, transforming, or shipping, where specific recordkeeping is triggered under the rule.
Key Data Element
The specific information, like lot code, quantity, date, and location, that must be captured and linked to each Critical Tracking Event.
Plan de trazabilidad
The written document describing how an entity assigns TLCs, maintains records, and stays ready for an FDA traceability request.
FSMA 204 FAQ
1What is FSMA 204?
FSMA 204 is Section 204(d) of the FDA Food Safety Modernization Act. It establishes additional traceability recordkeeping requirements for anyone who manufactures, processes, packs, or holds foods on the FDA's Food Traceability List (FTL).
2What is the FSMA 204 compliance deadline?
Covered entities must comply by July 20, 2028.
3What foods are covered under FSMA 204?
The rule covers 16 food categories on the Food Traceability List, including soft cheeses, shell eggs, nut butters, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical tree fruits, fresh-cut fruits and vegetables, finfish, crustaceans, mollusks and bivalves, and ready-to-eat deli salads.
4What are Critical Tracking Events (CTEs)?
CTEs are the points in the supply chain, such as growing, receiving, transforming, creating, and shipping, where the rule requires specific records to be captured. Most food manufacturers are directly responsible for a subset of these, typically receiving, transformation, and shipping.
5What are Key Data Elements (KDEs)?
KDEs are the specific data points, like lot code, quantity, product description, date, and location, that must be recorded and linked to each Critical Tracking Event.
6What is a Traceability Lot Code (TLC)?
A TLC is a unique code assigned to a lot of food at the point it's created or transformed. It's the thread that ties every record for that lot together across the supply chain.
7Who is required to comply with FSMA 204?
Any entity that manufactures, processes, packs, or holds a food on the Food Traceability List is covered, unless a specific exemption applies.
Continue Your FSMA 204 Research
FSMA 204 readiness, explained
Watch the on-demand session covering what covered entities need to have in place before the 2028 deadline.
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Lee la guía →Descubre la trazabilidad de Nulogy según la FSMA 204 en la práctica
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