Connect Traceability Information
Bring product, lot, & supply chain records together in a single connected food traceability management system with TransGenie.
Turn Traceability Chaos Into Control with TransGenie's FSMA 204 Traceability Software
When traceability data lives across suppliers, facilities, spreadsheets, and disconnected systems, finding the full product story can become the hardest part. Our FSMA 204 traceability software brings the information together, helping your team capture, connect, and retrieve the records that matter across the food supply chain.
FDAFood Traceability Rule
CTE & KDERecordkeeping
24-HourRecord Retrieval
No FDA Enforcement Before July 20, 2028
What is FSMA 204 Traceability Software
FSMA 204 traceability software, also known as FSMA 204 food traceability software, helps food businesses manage the traceability details needed to support compliance with the FDA's Food Traceability Rule. Our food traceability software keeps product and supply chain connected across the traceability events that apply to your operation.
Support CTE and KDE Recordkeeping
Organize traceability data around applicable Critical Tracking Events (CTEs) and Key Data Elements (KDEs) required under FSMA 204.
Build a Stronger Traceability Foundation
Our FSMA compliance software helps manage traceability details as products move through their operations & supply chain.
What FSMA 204 (the Food Traceability Rule) Requires
If your business handles foods covered by the FDA's Food Traceability List, FSMA 204 requires you to maintain specific traceability information across applicable points in the food supply chain.
01
Critical Tracking Events (CTEs)
Covered businesses must record traceability information when specific events occur, including receiving, transforming, and shipping.
02
Key Data Elements (KDEs)
Each applicable CTE has specific Key Data Elements that must be properly maintained to help identify and trace the food.
03
A Traceability Plan
Businesses subject to the rule must maintain a traceability plan that describes their procedures for maintaining required records.
04
Records Ready for Retrieval
Required traceability records must be available to the FDA within 24 hours of a request, unless the FDA agrees to a reasonable alternative timeframe.
05
Two-Year Retention
Records must be kept for two years from the date they were created, whether on paper, electronically, or as true copies.
Where the FSMA 204 Compliance Date Stands
FSMA 204's compliance date is now July 20, 2028. The FDA's Food Traceability Rule requirements have not changed - businesses simply have more time to prepare.
Originally: January 20, 2026
→
Now: July 20, 2028
Why Traceability Matters Beyond Compliance
At TransGenie, we know traceability matters most when your team needs answers. We help connect the information behind your food, so it is easier to understand where it came from, where it moved, and what records matter.
48 Million Foodborne Illnesses Every Year
Food safety incidents affect millions. Better traceability supports faster investigation and response, with 128,000 hospitalizations and 3,000 deaths annually. Source: CDC
When Time Matters, Information Matters
We help your team access relevant traceability information without piecing together disconnected records.
Traceability Goes Beyond Your Four Walls
Our software helps manage the information that follows your food across your operation and supply chain.
More than records. A more connected way to manage traceability.
How Ready Is Your Traceability for FSMA 204?
Answer five quick questions to get a clearer picture of your current FSMA 204 traceability readiness.
Why Spreadsheets Can Make FSMA 204 Traceability Harder to Manage
Spreadsheets can be used to maintain traceability records. However, as products move through multiple lots, locations, and supply chain events, keeping the right information organized and connected can become highly difficult.
01 · CHALLENGE
Records Can Live in Too Many Places
Traceability details may be spread across spreadsheets, production records, shipping documents, and other systems.
02 · CHALLENGE
Connections Must Be Managed Manually
Your team may need to manually check for products, lots, and records across applicable traceability events.
03 · CHALLENGE
Finding the Right Information Can Take Time
Finding the right records for a product, lot, or FDA request can take time when information is spread across multiple sources.
CONNECTED SYSTEM
A Connected System Changes the Process
TransGenie’s FSMA 204 traceability software brings traceability data under one system. Thus, your team can manage connected records instead of chasing scattered ones.
Which Foods Are Covered Under FSMA 204?
FSMA 204 applies to foods on the FDA's Food Traceability List (FTL), including certain foods that contain an FTL item as an ingredient. Our software helps you manage traceability for applicable foods without relying on manual cross-checks.
FTL foods include:
Soft and semi-soft cheeses
Shell eggs
Nut butters
Finfish, crustaceans, and mollusks
Ready-to-eat deli salads
Fresh-cut fruits and vegetables, leafy greens, melons, cucumbers, fresh herbs, peppers, sprouts, tomatoes, and tropical tree fruits
If covered foods move through your operation, your team may need to manage the applicable FSMA 204 CTE and KDE requirements.
Our FSMA 204 Traceability Platform, Built Around Your Food Business
From the information you record to the records you need to find later, traceability involves a continuous flow. Hence, we deliver FSMA 204 compliance software that helps your team manage that flow across the relevant parts of your operation and supply chain.
01
CAPTURE
Product & Lot Details
CTEs (Critical Tracking Events) & KDEs (Key Data Elements)
02
CONNECT
Products ↔ Lots ↔ Events
Keep traceability relationships linked
03
MANAGE
Relevant Activities Across Your Workflow
Receiving → Transformation → Shipping
04
FIND
Search → Trace → Retrieve
Get the relevant records when needed
Capture What Matters
Our software helps record the traceability details relevant to your products & applicable activities.
- Product and lot details
- Applicable Critical Tracking Events
- Associated Key Data Elements
Keep Products, Lots & Events Connected
Our software helps maintain the links between traceability information as products move through stages.
- Product-to-lot relationships
- Records across traceability events
- Info linked via product movement
Manage Traceability Across Your Workflow
Our software brings relevant lot traceability activities into a more structured process.
- Receiving and shipping activities
- Applicable transformation events
- Traceability across stages
Find Records When You Need Them
Our software gives your team a clearer way to access relevant traceability information.
- Search by relevant product details
- Trace specific lots
- Retrieve records when required
One Connected Flow. From Product In to Product Out.
TransGenie helps you manage traceability information across the relevant stages of your food operation - all in one system. Our FSMA traceability software is designed to support the way your business manages product and traceability information.
Everything You Need in FSMA 204 Traceability Software
From the details you are required to maintain to the records you may need to retrieve, our FSMA 204 compliance solution brings the key parts of your traceability process into one place.
CTE & KDE Management
Helps manage critical traceability events and key data elements throughout every stage of your operation.
Applicable Critical Tracking Events
Associated Key Data Elements
Organized traceability records
Product & Lot Relationships
Maintain the information needed to follow products and their traceability lot codes through applicable activities.
Product identification
Traceability lot information
Links across relevant events
Transformation Tracking
Helps manage traceability information when products are transformed or combined, where applicable to your operation.
Input and output relationships
Transformation details
Resulting product information
Record Search & Retrieval
Supports finding relevant traceability information when your team needs to investigate a product or respond to a request.
Product and lot searches
Connected record access
Retrieval of relevant information
See How TransGenie Supports Your FSMA 204 Traceability Process
FSMA 204 sets out what information businesses may need to maintain. Our FSMA 204 food traceability software helps you manage that information as part of your traceability process.
Your Traceability Needs
How Our Software Helps
Applicable CTEs
Organize traceability information around the events that apply to your operation
Associated KDEs
Manage the required details linked to applicable traceability events
Product & lot information
Keep relevant product and traceability lot information organized
Transformation activities
Manage traceability information through applicable product transformations
Record retrieval
Search for and access relevant traceability records when needed
Looking for FDA traceability software?
Our team can help you understand how TransGenie fits into your FSMA 204 traceability process.
Our FSMA 204 Traceability Software for Every Part of Your Food Business
Whether you manufacture, process, pack, or move food through the supply chain, your traceability process is shaped by the role you play. Our FSMA 204 traceability software helps you manage the information that matters to your operation.
01 · ROLE
Food Manufacturers
We build FSMA 204 software for food manufacturers to help you keep ingredient, product, and lot information organized as food moves through your manufacturing process.
Why Food Businesses Choose TransGenie
The right FSMA 204 compliance solution should fit your operation - not force your team into a one-size-fits-all process. That is how we approach food traceability at TransGenie.
01
Built Around Your Process
Our FSMA 204 traceability solution is built around the way your products move and the information you need to manage.
02
Designed for Real-World Food Traceability
Our food supply chain compliance software is built to support the way traceability information moves through food operations.
03
Support Beyond the Software
Our team at TransGenie works with you from implementation to ongoing traceability support as your needs evolve.
04
Ready to Grow With You
Our FSMA 204 compliance platform can support your business as products, processes, and operations grow.
What Changes When Your FSMA 204 Traceability Is Connected?
A connected traceability process can change the way your team manages and accesses information.
Without a Connected System
With TransGenie
Records may be spread across multiple sources
Traceability information is managed in one system
Teams may manually piece records together
Relevant information stays organized around your process
Finding a specific record can take time
Search by relevant product or lot information
Record retrieval may involve multiple files
Access relevant traceability records when needed
Processes can vary across teams and locations
Manage traceability through a more structured process
Find the Traceability Information You Need, When You Need It
From investigating a product to responding to a customer and retrieving traceability records, our FSMA 204 tracking system helps you quickly find the information relevant to your search.
Find the Product or Lot
Our FSMA 204 Traceability Software helps you quickly search for the product or lot you need to investigate.
Follow its Traceability Trail
You can review the relevant traceability information linked across applicable activities.
Access Needed Records
It is possible to retrieve the relevant records within the 24-hour window the FDA requires.
FAQ
1. What is FSMA 204 Traceability Software?
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FSMA 204 traceability software helps food businesses manage the traceability information needed to support the FDA's Food Traceability Rule.
2. What does FSMA 204 require from food companies?
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Businesses subject to the rule must maintain specific traceability records for applicable foods and events, including required Key Data Elements (KDEs), Critical Tracking Events (CTEs), and a traceability plan.
3. How does FSMA 204 Traceability Software work?
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The software helps manage traceability information as products move through applicable stages of an operation and supply chain, making relevant records easier to organize and retrieve.
4. What are Critical Tracking Events Under FSMA 204?
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Critical Tracking Events are specific points in the food supply chain where businesses must maintain the required traceability information for applicable foods.
5. What are Key Data Elements under FSMA 204?
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Key Data Elements are the specific pieces of traceability information businesses must maintain for each applicable Critical Tracking Event.
6. Who can use FSMA 204 Traceability Software?
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Our software is designed to support food manufacturers, processors, packers, and other food businesses managing traceability across their operations and supply chains.
7. What foods are on the FDA Food Traceability List?
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The FTL includes fresh-cut produce, leafy greens, cucumbers, peppers, tomatoes, tropical tree fruits, sprouts, fresh herbs, melons, certain finfish, crustaceans, molluscan shellfish, certain soft cheeses, shell eggs, nut butters, and ready-to-eat deli salads.
8. How long must FSMA 204 traceability records be kept?
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FDA guidance calls for a minimum two-year retention period for required KDE records.
9. What are the penalties for not complying with FSMA 204?
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The FDA does not directly fine Section 204 violations but can pursue civil or criminal action after allowing an opportunity for voluntary correction. Non-compliance can also trigger commercial consequences with retail trading partners ahead of the federal deadline.
10. What is a Traceability Lot Code under FSMA 204?
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A Traceability Lot Code (TLC) is a descriptor used to identify a traceability lot. It helps link the food to the traceability records associated with that lot.
11. When does FSMA 204 take effect?
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The FDA does not intend to enforce the Food Traceability Rule before July 20, 2028. The rule's requirements have not changed; businesses have additional time to prepare.
12. Does FSMA 204 apply to every food business?
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No. FSMA 204 applies to businesses that manufacture, process, pack, or hold foods on the FDA's Food Traceability List, subject to certain exemptions.
13. Can FSMA 204 traceability software replace a company's traceability plan?
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Software can help manage the information and records used in your traceability process, but businesses subject to FSMA 204 must maintain the required traceability plan and meet the applicable rule requirements.
14. Is TransGenie FDA FSMA 204 compliance software?
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Yes. TransGenie helps food businesses manage the traceability records, CTEs, and KDEs needed to support FSMA 204 compliance