FSMA 204 gap analysis and assessment
DNV supports food and beverage companies in achieving FSMA 204 compliance with tailored gap analysis and assessment services. Identify risks, close gaps, and improve traceability.
FSMA 204 gap analysis and assessment
Challenges in food traceability
The U.S. FDA’s Food Safety Modernization Act (FSMA) Section 204 is reshaping food traceability expectations across the food and beverage sector. Businesses that manufacture, process, pack, or hold items on the Food Traceability List (FTL) must now track and share Key Data Elements (KDEs) for all Critical Tracking Events (CTEs).
Increased consumer awareness, complex supply chains, and rising regulatory demands mean that compliance is more than a box-ticking exercise, it’s central to food safety, brand trust, and operational resilience. Many companies still rely on manual records or fragmented systems, which limits transparency and slows response times in the event of a food safety issue.
To meet the FDA’s expectations for traceability and recordkeeping – and to support proactive recall management – food and beverage companies must take a structured approach to evaluating their readiness and closing compliance gaps.
How our FSMA 204 services support you
DNV’s FSMA 204 gap analysis and assessment is designed to evaluate how well your current traceability processes align with FSMA Section 204 requirements. Through a combination of regulatory review, system mapping, and risk-based analysis, we help you build a traceability system that is fit for purpose, auditable, and future-ready.
Our service includes:
- Regulatory readiness review based on FDA’s traceability rule.
- Mapping of Critical Tracking Events (CTEs) and Key Data Elements (KDEs).
- Evaluation of current traceability data systems and interoperability.
- Risk prioritization by product, facility, or supplier tier.
- Customized roadmap to close compliance gaps and support digital traceability.
Whether you are early in your FSMA 204 journey or looking to validate existing systems, we offer flexible entry points such as workshops, pilot projects, and scalable enterprise solutions.
Trusted experts in the food industry
DNV is a globally recognized leader in food safety, supply chain assurance, and digital transformation. With decades of experience supporting the food and beverage industry, we understand the unique challenges of compliance in complex and fast-moving supply chains.
We bring:
- Proven methodologies aligned with FSMA, HACCP, and ISO frameworks.
- Cross-functional teams with regulatory, technical, and operational expertise.
- Deep knowledge of traceability systems, supplier management, and food safety risk.
- Support for digital data systems, ESG alignment, and transparent reporting.
Our goal is to help you implement traceability systems that not only satisfy FDA requirements but also build trust with customers and regulators.
Benefits of our FSMA 204 services
- Uncover and address FSMA 204 compliance gaps.
- Improve traceability data capture and interoperability.
- Reduce risk exposure through enhanced visibility.
- Support faster recall management and regulatory response.
- Save time and cost through targeted, risk-based improvements.
- Build consumer and stakeholder trust through verified traceability.
- Lay the groundwork for digital transformation and ESG reporting.
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