What Is FSMA 204 and Why It Matters for Food Processors

Food recalls have become a growing concern in recent years. In 2023, the Food and Drug Administration (FDA) issued more than 300 recalls due to pathogens, undeclared allergens, and foreign materials. To address these risks, the FDA introduced Section 204 of the Food Safety Modernization Act (FSMA 204), setting new standards for food traceability. 

By July 20, 2028 (previously January 20, 2026), food processors must comply with FSMA 204 to ensure supply chain transparency. This blog explores FSMA 204, its significance, who must comply, and strategies for integrating traceability solutions into existing supply chain ecosystems. 

FSMA 204 and Its Importance 

FSMA 204 is part of the Food Safety Modernization Act and focuses on improving food traceability to prevent illnesses.  Through the act, the FDA intends to increase transparency in the supply chain, making it easier to trace food from its origin to the final product. By adopting FSMA 204, food processors can reduce contamination risks and ensure public health while staying in line with current regulations. 

Who Must Comply with FSMA 204? 

FSMA 204 applies to a wide range of food sector entities, including: 

• Manufacturers 
• Processors 
• Packers 
• Distributors 
• Retailers 

All businesses must maintain detailed records and comply with traceability standards for foods listed on the Food Traceability List (FTL) such as leafy greens, fresh-cut fruits, seafood, cheese, and other high-risk, perishable foods in the supply chain. 

FSMA 204 Key Requirements 

FSMA 204 requires entities covered by the Food Traceability List (FTL) to maintain detailed records of different checkpoints.  

For example, when raw materials arrive at a processing facility, the company must record specific Key Data Elements (KDEs) for each Critical Tracking Event (CTE). These KDEs include details such as the source of the food, the date and time it was received, and any other relevant information needed to track its journey.  

Businesses must retain these records for at least two years and provide them to the FDA within 24 hours if requested.  

Benefits of FSMA 204 Compliance for Food Processors 

FSMA 204 compliance offers food processors several key advantages that go beyond avoiding federal penalties: 

• Strengthened Brand Reputation: Demonstrating a commitment to food safety and transparency improves consumer trust. 

• Proactive Risk Mitigation: Real-time traceability capabilities enable rapid identification of potential contamination sources, minimizing the impact of recalls. 

• Operational Excellence: The data collected can help companies improve their operations, reduce waste, and make more informed choices.  

From Compliance to Competitive Edge: Ways to Leverage Data to Build Resilient Supply Chains 

Companies that view FSMA 204 compliance as just another hurdle to cross may miss out on significant opportunities. Food processors can access a wealth of insights by integrating traceability systems with existing supply chain applications, such as ERP, WMS to: 

• Improve Operational Efficiency: Streamlined processes, and optimized inventory management, leading to significant cost savings.    

• Proactively Manage Risks: Gather real-time data from integrated systems to identify and address potential issues early on, improving supply chain resilience. 

• Make Data-Driven Decisions: Analyze data from integrated systems for valuable insights that could be used for continuous improvement. 

• Build a Sustainable Brand: Transparent and traceable supply chains enhance brand reputation.    

By integrating systems, food processors can achieve end-to-end supply chain visibility, gather business intelligence, and transform operations into agile, insight-driven supply chains that deliver long-term value. 

Why Choose CTG as Your Technology Partner for Achieving FSMA 204 Compliance 

At CTG we deliver tailored solutions, integration expertise, and end-to-end support to help food businesses achieve FSMA 204 compliance and strengthen their traceability systems.  

• Expert System Integration: With extensive experience in integration, we ensure seamless data connectivity, enabling real-time visibility and traceability. 

• In-Depth Regulatory Knowledge: We understand the complexities of FSMA 204 compliance and help organizations align with federal standards while maintaining operational efficiency. 

• Audit-Ready Technology: Our solutions streamline reporting, traceability, and recall readiness, ensuring full compliance and smooth audit processes. 

• Comprehensive Support: From initial strategy and system design to implementation and ongoing maintenance, we partner with businesses at every step to ensure compliance success. 

By partnering with CTG, food processors can build smarter, more connected supply chains that drive compliance and deliver lasting value. Contact us today to get started.