The Food Safety Modernization Act (FSMA) 204 sets a high bar for food traceability, introducing strict requirements for companies handling high-risk foods. By 2026, businesses across the supply chain must maintain comprehensive, real-time records of certain products listed on the FDA’s Food Traceability List (FTL). Achieving FSMA 204 compliance is a complex task that demands robust traceability systems, detailed record-keeping and fast recall responses.
AuditComply offers critical tools to simplify compliance and enhance food safety by providing tech-enabled traceability solutions. In a snapshot of our FSMA 204 webinar below, AuditComply walks through the essential requirements of FSMA 204. See the full webinar here.
1. Understanding FSMA 204’s Traceability Requirements
FSMA 204 mandates that companies track Critical Tracking Events (CTEs) such as harvesting, cooling, initial packaging and shipment, as well as capture Key Data Elements (KDEs) like lot codes, product types and shipping details at each step in the supply chain. These records must be maintained for 24 months and be accessible to the FDA within 24 hours upon request. This shift from a “one-step-forward, one-step-back” model introduces stringent new demands for real-time data capture across the supply chain, moving toward tech-enabled traceability to prevent delays during recalls or foodborne illness investigations.
For companies that handle products on the FDA’s Food Traceability List (FTL)—which includes items like leafy greens, seafood, and cheeses—AuditComply enables comprehensive tracking from farm to table. The platform automates data capture and offers real-time dashboards that monitor supply chain movements, ensuring that all required KDEs are logged.
2. The Case for Centralized, Digital Record-Keeping
One of the most critical components of FSMA 204 compliance is maintaining detailed, digital records. Paper-based systems are error-prone and slow, which is problematic when businesses are required to provide sortable spreadsheets to the FDA within 24 hours. AuditComply streamlines this by offering cloud-based, centralized repositories for all traceability data. This makes it easy for businesses to generate reports, share data across the supply chain, and quickly respond to audits or recalls. Digital records also enhance transparency, allowing for full visibility into each step of the product journey. AuditComply helps companies manage this complexity by providing real-time updates, enabling quick identification of at-risk products, and ensuring compliance with FDA regulations.
3. Managing Supply Chain Complexity with Enhanced Traceability
FSMA 204 applies to every link in the food supply chain, from growers to retailers. In practice, this means businesses must work closely with their suppliers to ensure all traceability data is captured correctly. Supply chain transparency is essential not only for compliance but also for building consumer trust and enhancing food safety. AuditComply, with its real-time data monitoring and supplier collaboration tools, enables seamless communication across the supply chain. AuditComply’s platform stitches together the various KDEs and CTEs into a single digital flow, ensuring that companies can track the movement of their products across different stages of production, packaging, and distribution. This enables businesses to manage risk proactively, identifying issues before they escalate into costly recalls.
4. Tech-Enabled Solutions for Modern Food Traceability
As the food industry evolves, adopting tech-enabled traceability solutions has become a competitive necessity. With FSMA 204 pushing businesses toward advanced record-keeping systems, solutions like AuditComply provide the tools necessary to keep pace with these regulatory demands. By leveraging cloud-based traceability, businesses can integrate real-time tracking capabilities with automated alerts and risk assessments, which help them stay compliant and agile in a fast-moving marketplace. This ensures not only regulatory compliance but also operational efficiency, as businesses can detect and resolve supply chain issues more swiftly.
5. Practical Steps for FSMA 204 Compliance
To achieve FSMA 204 compliance, businesses must take several key steps:
Develop a Traceability Plan: This plan should include detailed procedures for capturing KDEs at each CTE, managing records, and assigning traceability lot codes.- Collaborate with Suppliers: Ensure that all trading partners along the supply chain adhere to traceability requirements. Platforms like AuditComply facilitate seamless data exchange, making it easier to comply with the new rules.
- Implement Digital Record-Keeping: Digital solutions simplify the process of maintaining, storing, and retrieving records in compliance with FSMA 204.
By following these steps and adopting advanced tools like AuditComply, businesses can stay ahead of FSMA 204 compliance while also optimizing their supply chain for greater transparency and efficiency.
FSMA 204 represents a transformative shift in food safety regulations, making traceability more rigorous and demanding than ever. Compliance requires modern solutions capable of handling the intricate demands of data capture, reporting, and real-time visibility. AuditComply stands as a critical tool for businesses aiming to meet FSMA 204 requirements while improving operational efficiency and safeguarding consumer trust.
If you’re preparing for FSMA 204 compliance, request a demo of AuditComply today and explore how our platform can help your business navigate the evolving landscape of food safety.
