Food traceability follows the movement of food products and their ingredients through the entire supply chain, backward and forward. It involves documenting and linking the production, processing and distribution chain of food and ingredients.
The US Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) 204 aims to enhance food safety by improving supply chain traceability. The rule, also known as Requirements for Additional Traceability Records for Certain Foods, targets high-risk foods on the Food Traceability List and mandates detailed recordkeeping, traceability plans and rapid data sharing.
These measures support the swift identification and removal of contaminated food from the market, reducing risks and strengthening consumer trust. While the compliance deadline is January 20, 2026, many retailers are pushing suppliers for earlier adoption.
Meeting these requirements can be complicated, but with our integrated FSMA 204 traceability solutions – audits, training and the TRAKKEY digital traceability platform – you can confidently navigate compliance while enhancing your food safety management systems.
FSMA 204 audits: Be prepared and confident
Our FSMA 204 audits will help you meet the FDA's new traceability requirements while improving your supply chain resilience. Preparing for these audits is essential for compliance and helps safeguard public health by ensuring your rapid response to contamination events.
Our audits focus on verifying the accuracy, completeness and timeliness of your key data elements (KDEs) and critical tracking events (CTEs). During an FSMA 204 audit, we will assess if your traceability systems can quickly and accurately track food items through the supply chain to improve food safety and minimize risks. Our auditors will identify gaps in compliance, recommend tailored solutions to enhance operational efficiency and regulatory compliance, and validate your recordkeeping systems.
Stay ahead of FSMA 204 compliance with expert-led training
Ensure your team is fully prepared to meet FSMA 204 requirements with our expert-led training courses. Available online and face-to-face, our training courses provide in-depth guidance on FSMA 204 traceability rules, KDEs and CTEs. Through interactive sessions, case studies and practical exercises, you’ll gain the knowledge and skills necessary to implement a robust traceability plan and confidently navigate FDA inspections.
Introducing the TRAKKEY digital traceability platform
TRAKKEY, an enterprise-grade, digital platform, automates food traceability and enhances your FSMA 204 compliance journey with greater efficiency and data accuracy.
TRAKKEY is a powerful and scalable digital solution for real-time, supply chain-wide visibility that has been validated by billions of annual transactions in complex supply chains. TRAKKEY effortlessly integrates with your pre-existing IT systems and workflows, empowering you to enhance outbreak investigation, reduce recalls, improve product information and streamline line data sharing.
FAQs
When a foodborne illness outbreak or contamination event occurs, efficient product tracing helps government agencies, producers and sellers to rapidly determine the product’s source and where contamination may have occurred. This means the affected product can be removed from the market quicker, reducing incidences of foodborne illnesses.
Food traceability regulations, such as the FDA’s FSMA 204, also impact local and international food suppliers selling to large markets like the US.
Big retailers, including Kroger and Walmart in the US, are also imposing traceability requirements across their food supply chains.
The US Food Safety Modernization (FSMA) Act Section 204 requires food businesses to implement more robust traceability systems for certain high-risk foods. It mandates detailed recordkeeping and rapid data sharing to improve food safety, minimize contamination risks and ensure swift responses to outbreaks.
Compliance can impact your operations by requiring more stringent tracking and documentation practices, potentially necessitating system upgrades or process changes.
The high-risk foods under the Food Traceability List are those most susceptible to contamination or that pose higher risks to public health, such as ready-to-eat products, leafy greens, shellfish and others identified by the FDA due to historical foodborne illness outbreaks.
Please visit the FDA’s web page for more information.
FSMA 204 requires detailed records for key data points, including the source, location and handling of food products, as well as any temperature, humidity and movement data during transportation.
Organizations must trace food products from farm to table and provide this data in the event of an outbreak or investigation.
The compliance deadline is January 20, 2026. Failing to comply by this date can result in penalties, including regulatory actions, fines and potential restrictions on your ability to operate or ship products within certain markets.
To create a traceability plan, you must identify your product’s critical data points, implement systems to capture and track this data and establish processes for sharing the information with authorities during an investigation or recall. You can leverage tools like TRAKKEY to streamline this process and ensure compliance.
Implementing digital platforms like TRAKKEY can automate data collection and provide real-time access to traceability records. These systems allow you to respond to FDA requests quickly, reducing the time and resources needed for investigations.
Yes, penalties for noncompliance include fines, legal consequences and potential business disruptions, including the suspension of shipments and product recalls.
Ensure your suppliers adhere to FSMA 204 by setting clear compliance expectations, requesting certifications and using traceability tools like TRAKKEY to monitor data from their operations. Regular audits and communication are also essential.
Technologies like TRAKKEY for traceability can help streamline compliance by automating data collection, offering real-time insights and ensuring accurate recordkeeping.
FSMA 204 enhances food safety by ensuring that food products can be quickly traced back to their source in the event of contamination, helping to prevent widespread outbreaks. It builds consumer trust by demonstrating a commitment to food safety through transparent and efficient tracking systems.
TRAKKEY is a digital traceability platform that supports any food industry organization’s FSMA 204 compliance by capturing and storing critical data on food products. It helps businesses track and trace their products in real time, ensuring accurate recordkeeping and seamless data sharing during investigations.
TRAKKEY captures data on the origin, processing, transportation and storage conditions of food products, including temperature, humidity and movement. This data is securely stored in the cloud and can be shared with regulatory bodies or stakeholders, as needed.
TRAKKEY is designed to integrate seamlessly with existing systems, including ERP, production and governmental platforms, making it easy to incorporate it into your operations without significant disruption.
TRAKKEY is highly customizable to meet the specific needs of different businesses. Whether you need specific data capture points or tailored reporting features, the platform can be adapted to suit your unique traceability requirements.
The price depends on the size of your operations and the level of customization required. However, investing in these traceability solutions can provide a strong return on investment by reducing the risk of recalls, improving efficiency and ensuring FSMA 204 compliance.
By providing real-time data and seamless traceability, tools like TRAKKEY enable quick identification of contaminated products, minimizing the impact of contamination events and speeding up recalls to protect consumers.
Yes, comprehensive training and ongoing support are available to ensure your team can fully leverage the capabilities of TRAKKEY, ensuring smooth implementation and optimal usage.
You can trust TRAKKEY because it is deployed globally by thousands of business entities, has set over 4.5 billion product passports in five years, and integrates with over 50 production systems, 10+ ERP systems, and 5+ governmental systems for data exchange and reporting. It is also a winner of the FDA‘s Low-Cost Food Traceability Challenge and certified against ISO 9001, ISO/IEC 27001 GDPR and FDA 21 CFR Part 11.
