FSMA 204 Compliance: How VAI ERP Helps You Stay Audit-Ready

FSMA 204 compliance requires food companies to maintain fast, accurate, and digital traceability records across the supply chain. The regulation shifts food safety away from fragmented, manual processes and toward end-to-end visibility where speed and accuracy are mandatory.

Many food and beverage organizations still rely on paper logs, spreadsheets, or disconnected software. These approaches cannot meet FSMA 204 requirements when regulators demand complete traceability data within hours.

What Is FSMA 204?

FSMA 204 is an FDA regulation under the Food Safety Modernization Act that establishes enhanced traceability requirements for high-risk foods.

Its goal is to help the FDA:

• Quickly identify the source of foodborne illnesses

• Reduce the size and impact of food recalls

• Improve overall food supply chain transparency

Companies that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) must maintain digital traceability records covering every critical stage of product movement.

Why Is FSMA 204 Important?

FSMA 204 is important because it raises regulatory expectations for traceability speed, accuracy, and documentation.

The regulation requires companies to:

• Track products at the lot level

• Capture standardized traceability data

• Produce complete records quickly during audits or recalls

Failure to comply can result in delayed recalls, regulatory penalties, operational disruption, and reputational risk. For many organizations, FSMA 204 compliance is now a core operational requirement—not just a regulatory task.

What Does FSMA 204 Require?

Critical Tracking Events (CTEs)

Critical Tracking Events (CTEs) are specific points where food changes location, ownership, or form.

FSMA 204 requires documentation of events such as:

• Receiving

• Creation

• Transformation

• Shipping

• Harvesting (when applicable)

Each event must be recorded consistently to maintain a complete product history.

Key Data Elements (KDEs)

Key Data Elements (KDEs) are the required data points captured at each Critical Tracking Event.

These include:

• Lot or batch numbers

• Quantities

• Dates and times

• Supplier and customer identifiers

• Shipping and receiving information

KDEs enable regulators to trace products backward and forward through the supply chain quickly and accurately.

Foods Covered by FSMA 204

FSMA 204 applies only to foods on the FDA’s Food Traceability List.

Examples include:

• Fresh produce

• Seafood

• Cheeses

• Ready-to-eat foods

• Nut butters and other high-risk categories

Common Traceability Gaps That Put Compliance at Risk

Many food companies face FSMA compliance challenges due to:

• Paper-based records and spreadsheets

• Disconnected production, warehouse, and logistics systems

• Limited real-time lot-level visibility

• Slow or incomplete recall processes

• Inconsistent data formats

• No single source of truth

These gaps make it difficult to respond to FDA audits accurately and within required timeframes.

How VAI ERP Supports FSMA 204 Compliance

Automated Capture of CTEs and KDEs

VAI ERP automatically captures traceability data across operations, eliminating manual entry and reducing errors. This ensures records are accurate, standardized, and audit-ready.

Real-Time Lot-Level Tracking

VAI ERP provides real-time visibility into lot and batch movements across production, warehousing, and distribution, enabling instant traceability.

Faster Recall and Audit Response

With VAI ERP, companies gain:

• End-to-end traceability

• A centralized system of record

• Immediate access to historical product data

This allows teams to respond to recalls and audits in minutes instead of days.

Standardized Compliance Recordkeeping

Consistent workflows ensure that traceability data is captured uniformly across all facilities and processes.

Built-In Food Safety Controls

VAI ERP supports:

• Allergen tracking

• Shelf-life and expiration management

• Supplier data visibility

These controls strengthen food safety while supporting regulatory compliance.

Scalability for Future Regulations

VAI ERP provides a scalable foundation that supports evolving food traceability and compliance requirements beyond FSMA 204.

Why a Connected Technology Ecosystem Matters

FSMA 204 compliance requires integrated systems, not siloed tools.

VAI ERP integrates with:

• WMS for lot handling and storage conditions

• PLM for formulations, allergens, and labeling

• TMS for shipping and delivery traceability data

• EDI for supplier and retailer data exchange

This connected ecosystem ensures traceability data flows seamlessly across the supply chain.

Why Food & Beverage Companies Trust VAI ERP

Food and beverage organizations trust VAI ERP because it offers:

• Deep industry expertise

• Proven food safety and compliance capabilities

• Scalable, cloud-based technology

• Centralized documentation and reporting

• Real-time operational visibility

VAI ERP is purpose-built for regulated food environments.

Ready to Strengthen Your FSMA 204 Compliance?

FSMA 204 compliance requires visibility, speed, and accuracy. VAI ERP delivers the digital infrastructure food companies need to stay audit-ready and protect their brands.

Request a personalized demo to see how VAI ERP supports FSMA 204 compliance in real-world operations.

FAQs About FSMA 204 & ERP Compliance

What data does FSMA 204 require?

FSMA 204 requires capturing Key Data Elements such as lot codes, quantities, dates, and supplier/customer information at each Critical Tracking Event.

Do all foods require FSMA 204 traceability records?

No. FSMA 204 applies only to foods listed on the FDA’s Food Traceability List.

How quickly must companies respond to FDA audits?

Companies must provide complete traceability records within a short timeframe defined by the FDA, making digital ERP systems essential.